Principal Programmer Resume Samples

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MC
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Myrtie
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+1 (555) 710 4491
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Philadelphia
PA
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Experience Experience
New York, NY
Principal Programmer
New York, NY
Roberts and Sons
New York, NY
Principal Programmer
  • Will Develop Workflows using Informatica
  • Performs Java Development
  • Ensure that documentation on all modifications is created in accordance with established departmental procedures
  • Work with third party vendors as necessary to create and facilitate the interfacing of vendor hardware and software with application(s)
  • Work with System Administrators to optimize administrative application
  • Develop and promote best practices for documentation, unit testing, and code reviews
  • Test latest releases in the development environment to ensure functionality of the delivered product
Philadelphia, PA
Senior Principal Programmer, Clinical
Philadelphia, PA
Feil Group
Philadelphia, PA
Senior Principal Programmer, Clinical
  • Assist Data Manager in eCRF development
  • Provide technical expertise and support to Data Management team
  • Review synopsis and provide Data Manager with comments for the Synopsis Review Committee (SRC) meeting
  • Review synopsis and/or protocol and provide comments for the Review Committee
  • Develop, program, test and maintain computer validation/edit checks in PL-SQL and/or SAS
  • Provide clinical programming input into the SOW activities and review associated budget
  • Lead the development and maintenance of data review listings in SAS and/or reporting tools for data review purposes
present
Los Angeles, CA
Senior Principal Programmer, Statistical
Los Angeles, CA
Bernhard-Rutherford
present
Los Angeles, CA
Senior Principal Programmer, Statistical
present
  • Oversee the services provided by CROs
  • Perform ad hoc flexible and rapid programming arising from questions generated from planned analyses and results
  • Provide input to the design of the clinical trial database for proper data capture and to ensure data quality
  • Perform programming validation to ensure the quality of analysis datasets and programming outputs
  • Contribute to the creation of naming conventions and development of the programming environment
  • Provide training on departmental SOPs/WPs and standard programs
  • Write SAS programs to generate derived analysis datasets, perform analysis, and TFLs
Education Education
Bachelor’s Degree in Life Science
Bachelor’s Degree in Life Science
Carnegie Mellon University
Bachelor’s Degree in Life Science
Skills Skills
  • Good knowledge of statistical terminology, clinical tests, medical terminology, and protocol designs
  • Good interpersonal, communication, writing and organizational skills
  • Excellent communicator across disciplines
  • Proven ability to expertly diagnose issues and solve complex problems
  • Expert knowledge of Unity
  • Commercial experience on scalable distributed systems
  • Good planning and project management skills
  • Demonstrated proficiency in using SAS to produce derived analysis datasets and TFLs
  • Demonstrated ability to work in a team environment with clinical team members
  • Expert C# experience and high proficiency in writing optimized real-time code
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15 Principal Programmer resume templates

1

Senior Principal Programmer Resume Examples & Samples

  • BA/BS degree in life science, statistics, mathematics, computer science, or related field OR equivalent working experience required
  • 7-10 years Pharmaceutical/CRO experience as a SAS programmer supporting clinical trials for regulatory submissions
  • Demonstrated knowledge in programming environments, systems and networking as it relates to the pharmaceutical industry
  • Have in-depth understanding of clinical data structure as well as relational databases
  • Demonstrated proficiency in using SAS
  • Demonstrated skills in using software tools and applications, e.g., MS office, XML, HTML, etc
  • Have an understanding of regulatory requirements pertaining to technology, systems, and standards
  • Ability to research new technologies and ensure alignment with regulatory agencies and industry standards
  • Demonstrated ability in the handling and processing of upstream data
  • Demonstrated ability in providing outputs to meet downstream requirements
  • Excellent planning and project management skills
2

Principal Programmer Resume Examples & Samples

  • Will Develop Workflows using Informatica
  • May interact with the client or other teams to gather requirements
  • Will develop/program applications using Oracle Database and must be proficient with SQL
  • 4+ years experience with Informatica Development
  • At least 4+ years of total Software Development experience
  • At least 4+ years of recent solid Oracle Experience
  • Knowledge of version; revision control practices and Configuration management procedures
  • CMS experience
  • Healthcare Experience
  • Working experience with large data volumes
3

Principal Programmer Resume Examples & Samples

  • Perform direct calls to databases such as ADABASE, Oracle, SQL Server, IBM Web Sphere, and DATACOM DB
  • Perform software development life cycle activities following CMMI protocol to include but not limited to: Analysis, Design, Programming and development of testing plans to include providing requirements traceability matrices, Implementation/Release, Training and Documentation
  • Utilizing Best business practices such as Business Analysis Book of Knowledge (BABOK), Project Management Book of Knowledge (PMBOK), Information Technology Infrastructure Library (ITIL) v3.0, Capability Maturity Model Integration (CMMI), Lean Six Sigma, Agile methodologies and other best practices
  • Analyze log/error files to determine cause of problem and implementing a solution to resolve without major impact to software operations
  • Utilizing software configuration management principles/software including, but not limited to, CC Harvest/CACSM, Endevor and NATURAL N2O configuration management tools
  • Implement an SQA program and monitor execution of software utilizing CMMI standards, configuration management, and effective measurements
  • Utilizing Common Access Card (CAC)/server-to-server authentication technologies to design and implement application software solutions
  • Solving simple, intermediate and complex technical or production problems/software changes via software development or maintenance
  • Generating Business cases, point papers, recommendations and other technical advice to ensure an integrated solution is reached and does not compromise existing business. Generating documentation/artifacts to support/sustain best business practices
  • Developing/maintaining software in accordance to DoD and C4 policies,
  • Knowledge of the following tools: CA ENDEVOR, CCC HARVEST/CACSM, NATURAL N20, File AID, EXPEDITOR, TOAD, ORACLE DEVELOPMENT SUITE, Pro C complier, IBM 360 ASSEMBLER COMPILER, VS II COBOL COMPILER, XML parsers, MQ Series, Integrated Development environments (IDE)(JDeveloper, Eclipse,etc.), ime Sharing Option (TSO), Job Control Language (JCL), Bugzilla
4

Principal Programmer Resume Examples & Samples

  • Performs Java Development
  • Will develop/program applications using Data Exchange
  • 2+ years experience with installation; configuration; integration and management of IBM DataPower Appliances
  • At least 4+ years of recent solid Java experience
  • Experience in Data Exchange development required
  • Working knowledge of web application development using MVC frameworks
  • Working experience with application development for the Oracle WebLogic and Service Bus platforms
5

Senior Principal Programmer Statistical Resume Examples & Samples

  • Convert, verify and integrate multiple sources of incoming data for the creation of analysis datasets
  • Provide training on departmental SOPs/WPs and standard programs
  • Routinely interface with cross-functional team members
6

Principal Programmer, Statistical Resume Examples & Samples

  • Serve as the lead programmer in support of NDAs, sNDAs
  • Provide training on SOPs, WPs and standard programs
  • Bachelor’s Degree in life science, statistics, mathematics, computer science, or related field is required; Master’s
  • Degree is preferred
  • 7 plus years Pharmaceutical/CRO industry experience as a SAS programmer supporting clinical trials for
  • Data formats
  • Demonstrated expertise in providing outputs to meet downstream requirements, e.g., ADaM, Data Definition Table,
  • E-submission
  • Good knowledge of statistical terminology, clinical tests, medical terminology, and protocol designs
7

Senior Principal Programmer, Clinical Resume Examples & Samples

  • Review synopsis and provide Data Manager with comments for the Synopsis Review Committee (SRC) meeting
  • Review protocols for proper data capture including case report form design
  • Review eCRF specification according to the protocol
  • Assist Data Manager in eCRF development
  • Develop, program, test and maintain clinical trial databases and data entry screens using Oracle Clinical or Central Designer in accordance with Celgene standards
  • Review computer validation/edit checks for in-house and outsourced studies
  • Develop, program, test and maintain computer validation/edit checks in PL-SQL and/or SAS
  • Develop, program, test and maintain data review listings in Oracle Clinical, Inform, Jreview and/or SAS for data review purposes
  • Perform external data loads, i.e., labs, ECGs, etc., as needed. Act as liaison with vendors to establish transfer specifications and Celgene standards
  • Validate peer programming
  • Participate in and lead team meetings when appropriate
  • Act as primary CRO contact, when necessary, to ensure that Celgene standards are implemented in all studies
  • Make data, including interim data, available to company personnel and regulatory agencies when required
  • Perform post processing of data extracts in accordance with Celgene standards to be delivered to Biostatistics
  • Influences other functions and represents as DBO technical expertise
  • Internal team leader who decides best course of action
  • Manage outside CROs and consultants
  • Review clinical programming activities and costs in contracts
  • Assess CRO data management systems for regulatory compliance
  • Interact with CROs in the design and development of databases that are compatible with company needs
  • Monitor progress of clinical programming activities in CROs
  • Participate in regular team meetings and provide input when appropriate
  • Other Activities
  • Participate in the development of clinical programming SOPs and the development/optimization of clinical programming processes from study start up to database lock
  • Routine interface with cross-functional team members in creating an appropriate database, data quality assurance, and support of data cleaning activities
  • Direct responsibility for supervising and training junior clinical programmers in the performance of their duties
  • Managing project priorities and timelines
  • BS/BA degree or equivalent in a relevant scientific discipline with a minimum of five years experience
  • Advanced knowledge of clinical database design is a must (Inform, Oracle Clinical or other systems)
  • Experience managing clinical programmers
  • Participation in at least one NDA is preferred
  • Good communication skills; ability to work in a team environment with data managers, medical personnel, clinical monitors, statisticians, programmers, and medical writers
  • Detailed knowledge and experience in case report form design, central laboratories, programming databases, query resolution, data validation
  • Knowledge of SQL and SAS programming
  • Computer skills: detailed knowledge of clinical database design (Oracle Clinical or Inform), proficiency with SAS data sets and conversion procedures, knowledge of MS Office program suite
8

Senior Principal Programmer, Statistical Resume Examples & Samples

  • Ensure consistency and adherence to standards within their therapeutic area
  • Provide input to the design of the clinical trial database for proper data capture and to ensure data quality
  • Coach and advise junior programmers to identify problems and solutions
  • 9 plus years Pharmaceutical/CRO experience as a SAS Programmer supporting clinical trials for regulatory submissions with a Bachelor’s degree; or 8 plus years experience with a MS/MA degree
  • Demonstrated expertise in the handling and processing of upstream data, e.g., multiple data forms, workflow, eDC, SDTM
  • Good interpersonal, communication, writing and organizational skills
9

Principal Programmer Resume Examples & Samples

  • 5 years of PL/SQL
  • Oracle DB structure and practices
  • Oracle development for procedures and triggers
10

Principal Programmer Resume Examples & Samples

  • Perform programming validation to ensure the quality of analysis datasets and programming outputs
  • Serve as a coordinator when multiple programming resources (e.g. CROs or contractors) are used
  • Bachelor’s Degree in life science, statistics, mathematics, computer science, or related field is required; Master’s Degree is preferred
  • 7 plus years Pharmaceutical/CRO industry experience as a SAS programmer supporting clinical trials for regulatory submissions
  • Good planning and project management skills
11

Principal Programmer, Standards Liaison Resume Examples & Samples

  • Lead programming support for data standards managed by the Clinical Data Standards & Integration (CDSI) group (including SDTM and ADaM standards)Work with CDSI to support the implementation and maintenance of standards including but not limited to
  • BA/BS in a relevant health science or computer science discipline; minimum experience: 9 plus years as a programmer with progressive responsibilities in a pharmaceutical/CRO setting, or comparable relevant experience. Medical or mathematics/computer science background a plus
  • Advanced knowledge of programming in at least one data management system (Medidata Rave experience is a plus) and/or experience programming in SAS
  • Solid understanding of the clinical study life cycle including eCRF Development, external data handling, data validation and creation of metadata for data capture systems such as Rave
  • Proficiency with SAS datasets and programming procedures, knowledge of MS Office program suite
  • Advanced knowledge of the SDTM and/or ADaM models, CDISC controlled terminology, define.xml, creation of data specifications and annotated CRFs
  • Knowledge of clinical trial design and basic statistics
  • Ability to independently develop novel processes
  • Good leadership, communication, and project management skills
  • Ability to work effectively in a team environment with medical personnel, study managers, project managers, clinical monitors, data managers, medical writers, programmers, and statisticians
  • Knowledge of FDA/ICH guidelines and industry standard practices regarding clinical or statistical programming
  • Supervisory experience a plus
12

Principal Programmer / Technical Lead Resume Examples & Samples

  • As part of Airport Technology team, responsible for analyzing and integrating different enterprise technologies to fit and optimize business processes at the airports
  • Work closely with business units, project managers, developers, architects, QA engineers, technology providers, vendors, and other application teams to achieve individual project goals
  • Evaluate new technologies and present technical solutions to the architecture board for approval
  • Tune web and mobile applications for performance. Assess scalability requirements and resolve any potential issues
  • Deploy and tune applications on Tomcat/TC server/Web sphere application servers
  • Develop and tune application with JQuery , AngularJS and mobile application performance tuning
  • Develop and tune in-memory cache technologies
  • Evaluate applications for PCI security policies
  • Implement applications with Distributed Services, Real Time, Event Driven, Event Bus, Sockets, Messaging and Parsing
  • Design, prototype, and develop of applications in core Java, J2EE and .NET, websphere MQ technologies
  • SQL, Java/C++/VB, Batch and PowerShell scripting
  • Build automated scripts using Maven to deploy applications
  • Work on agile team
  • J2EE, core Java, .NET, .NET Compact Framework
  • IBM Websphere 6.x.; Hibernate ORM framework, Spring framework
  • Implementing Distributed Services, Real Time, Event Driven, Event Bus, Sockets, Messaging
  • Measuring, Resolving Performance, Scalability and Concurrency issues on Linux and windows as well as mobile applications
  • Developing, Deploying and tuning applications on Tomcat/TC server/Web sphere application servers
  • Developing and tuning applications with JQuery and mobile applications
  • Working with In-memory cache solutions
13

Principal Programmer / Technical Lead Resume Examples & Samples

  • Java, J2EE, EJB, Hibernate, JMS, Servlets, JSP, jUnit, Spring, SQL, PL/SQL, Struts
  • Web Development : AngularJS/ JQuery/HTML5/Javascript/CSS/AJAX
  • EHCache framework, Quartz Scheduling
  • Web Services(SOAP & REST) using Apache CXF, ApacheAxis, Spring Webservices
  • Build Frameworks – ANT, Maven
  • Database modeling within Oracle platform
  • IBM Websphere platform, WebSphere MQ, IBM Datapower
  • Agile Methodology, Test-driven development
  • Proficient in the following tools: myEclipse, SOAP UI, SQL Developer / TOAD, Code Coverage/Review tools
  • Extensive experience in software life cycle (development, deployment, and operations support) is required
  • Strong analytical skills with ability to learn quickly
  • Ability to lead and mentor developers
  • Show initiative, is a self-starter, able to handle multiple priorities and has excellent time management skills
  • 1-3 years of technical team leadership experience or 7+ years of direct experience in software development
  • Bachelor's degree in Computer Science, Engineering, Business or closely related field or equivalent
  • Previous work experience on an Agile team is a plus
14

Senior Principal Programmer, Statistical Resume Examples & Samples

  • Contribute to the creation, maintenance, and validation of standards for outputs and macros
  • Contribute to the creation of naming conventions and development of the programming environment
  • Prerequisites
  • Bachelor’s Degree with 7 plus years Pharmaceutical/CRO experience as a SAS Programmer supporting clinical trials for regulatory submissions
  • Celgene complies with all applicable national, state and local laws governing non-discrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S
15

Principal Programmer / Technical Lead Resume Examples & Samples

  • Guide and govern code based best practices and standards
  • Subject matter expert (SME) on projects for SOA, architecture and integration
  • Work with team to define project requirements, specifications, and effort estimates
  • Assist on complex development projects
  • Complete appropriate documentation for technical designs, processes engineering, and project decisions
  • Work with software architects to ensure decisions meet long-term enterprise growth needs
  • Undergraduate degree in CS/CE/CIS/MIS or Engineering/Technology or related field or equivalent experience/training
  • 12+ years of total software development experience
  • Expert in developing enterprise software solutions in a .NET environment
  • Expert coding knowledge regarding industry best practices (SOA, OOP/OOD) and patterns
  • Extensive knowledge of design patterns and best practices
  • Strong understanding of PCI, SOX, PII and security processes and standards
  • Strong background in Microsoft SQL Server, Oracle, and other data solutions
  • Strong use and understanding of Team Systems (TFS) is preferred
  • Strong expertise with user interface design and usability testing is highly desirable
  • Excellent analytical thinking and problem-solving abilities
  • Demonstrated organizational skills and attention to detail
  • Willingness to guide and willingness to learn
  • Strong focus on customer service and teamwork
  • Ability to manage conflicting interests and identify compromises
  • Ability to effectively meet deadlines and prioritize projects in a dynamic and fast-paced work environment
  • Preferred experience in an Agile environment
  • Business knowledge of airline systems is a plus
16

Associate Principal Programmer Resume Examples & Samples

  • With a BA/BS, 9 to 12 years’ experience in Statistics, Software Development, Clinical Data Management, Clinical Research, or Database Design & Development
  • With an MS, a minimum of 5 years’ experience in Statistics, Software Development, Clinical Data Management, Clinical Research, or Database Design & Development
  • Understanding of statistics, clinical, medical monitoring and data management concepts as applied to drug/vaccine development within Pharmaceutical industry
  • Strong understanding of clinical trial randomization, blinding and unblinding processes and tools
  • Broad knowledge in development of Analysis and Reporting deliverables for Research &Development (R&D) projects (data, analyses, tables, graphics, listings)
  • Good working knowledge of SAS programming and experience with blinding and unblinding of database
  • Strong project management skills with the ability to lead at a program level, determine an approach, ensure consistency and direct the development effort of others when opportunities arise
  • Excellent written oral and presentation skills
  • Strong collaboration, negotiation and organization skills
  • Broad knowledge of data structures and corresponding tools used to blind and unblind data; manage, extract, analyze & report data
  • Knowledge of pharmaceutical regulations related to data security and traceability when data is analyzed (e.g. 21 CFR Part 11)
  • Six Sigma and/or Process Improvement Certification
  • Experience with MS Visio and MS Project
  • Experience with developing training content including videos
  • Website management
17

Senior Principal Programmer Resume Examples & Samples

  • Leads staff involved in writing and updating technical documentation such as users manuals, product specifications, and training materials
  • 10-15 years of directly related computer programming experience. Experience with an integrated process, preferably CMMI
  • 5 years' experience of working within a team setting of 5 or more
  • Experience with Design Development
  • 3 years' experience of Visual Studio
  • 3 years' experience of Version Control/Configuration Management (preferably SVN)
  • At least 2 years' experience working with Front End Interfaces
  • Detailed knowledge of the following skills
18

Principal Programmer Resume Examples & Samples

  • Fluent English (oral and written)
  • Advanced knowledge of / experience with SAS and other relevant programming software
  • Proven experience in development of advanced MACROs with high programming efficiency; strong programming and problem-solving skills
  • Good understanding of regulatory requirements relevant to statistical programming (e.g. GCP, ICH). Intermediate knowledge of office tools
  • At least 8 years work experience in a programming role preferably supporting clinical trials/ or in pharmaceutical industry (5 years for MSStatistics / Computer Science)
19

Principal Programmer Resume Examples & Samples

  • Create, maintain and optimize game features
  • Produce professional quality C# code
  • Identify and communicate best practices for both front-end and back-end engineering
  • Proactively highlight and solve potential issues in the code and tool-chain
  • Deliver the Product Lead’s vision of the core game
  • Develop and promote best practices for documentation, unit testing, and code reviews
  • Expert C# experience and high proficiency in writing optimized real-time code
  • Expert knowledge of Unity
  • Superb time management and organisation skills
  • Must be proactive, self-directed, detailed and organized
  • Proven ability to expertly diagnose issues and solve complex problems
  • Excellent communicator across disciplines
20

Principal Programmer Resume Examples & Samples

  • Proficiency in the CICS/COBOL language, JCL and DB2
  • Experience with MQ Series is a plus
  • Experience with CMMI guidelines is also a plus
21

Principal Programmer / Analyst Resume Examples & Samples

  • Knowledge of basic computer skills (MS Word, Excel, PowerPoint, Outlook)
  • Ability to manage conflicting demands and priorities and to negotiate successfully
  • Project management or relevant experience
  • Review and input into key documents at the project level (e.g. submission documents, clinical reports and publications). May author or co-author reporting analysis plans and department level documents (e.g. SOPs, working practice document)
  • Act as key statistical programming contact for internal and external business partners
  • Identify recurring problems and initiate process improvement
22

Senior Principal Programmer Resume Examples & Samples

  • Mentor/coach programmers on functional expertise and process for project support across CSUs within the Franchise; Act as a programmer expert for problem-solving in programming/computing aspects within the Franchise. Act as a programmer expert within the Franchise for training and/or development of new programming applications
  • As required, act as a programmer representative on major process improvement initiatives and/or other non-clinical project activities
  • Expert knowledge of / experience with SAS and other relevant programming software
  • Proven experience as a strong programmer lead for clinical project(s) and submission activities (equivalent)
  • Working knowledge of database design/structures and basic statistics. Working experience of leading pooling analysis datasets across multiple clinical studies for clinical development program (or equivalent)
  • Good understanding of global / project practices, procedures, methodologies
  • Advanced knowledge of office tools
  • Proven ability to review / assess new programming applications / software
  • Proven ability to effectively act as a programmer represent at
23

Associate Principal Programmer Resume Examples & Samples

  • Broad knowledge and significant experience in developing analysis and reporting statistical programming deliverables (datasets, statistical analyses, report tables, and graphics) using global and TA standards and according to quality, compliance and timeliness requirements
  • Expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH; systems and database expertise. Familiarity with statistical analysis methods and clinical data management concepts
  • US and/or worldwide drug or vaccine regulatory application submission experience at the leadership level including the development of electronic submission deliverables
  • Ability to comprehend statistical analysis plans which may describe statistical methodology to be programmed; Understanding of statistical terminology and concepts Designs and develops complex programming algorithms
  • Demonstrated success in the assurance of deliverable quality and process compliance
  • Experience providing technical and/or programming guidance and mentoring to colleagues
24

Associate Principal Programmer Resume Examples & Samples

  • With an MS, a minimum of (5) years’ experience in Statistics, Software Development, Clinical Data Management, Clinical Research, or Database Design & Development
  • Excellent interpersonal skills and ability to negotiate and collaborate effectively; Ability to engage key stakeholders
  • Broad knowledge in statistical programming and developing Analysis and Reporting deliverables for research and development projects (datasets, analyses, tables, graphics, listings)
  • Good working knowledge of reporting systems and standard report capabilities using SAS programming. Demonstrated experience in complex data reporting in a statistical environment
  • Comprehensive knowledge of operating procedures, regulatory requirements (e.g. 21 CFR Part 11) and software development life-cycle (SDLC)
  • Thorough understanding of statistics, clinical, medical monitoring and data management concepts as applied to drug/vaccine development within Pharmaceutical industry.  
  • J-Review/I-Review knowledge
25

Cloud Principal Programmer Analyst Resume Examples & Samples

  • Minimum 8-9 years’ relative work experience in technology industry
  • 5-6 years of work experience focused on data visualization quantitative analysis
  • 2+ years experience with Installing and configuring OBIEE, OAE, ODI and Oracle’s pre-built applications
  • Understanding of data warehousing concepts (ETL, data modeling, reporting), data mining, machine learning and data sciences
  • Strong developer knowledge of XML, Java/J2EE, Javscript, OA, OracleJET, Framework/Fusion Application Developer Framework, Oracle Application Express (Apex), BI Publisher, Oracle Middleware and Database Technologies
  • ER Data Modeling expertise
  • Excellent communication and interpersonal skills, with the ability to be personable yet persistent
  • Understanding of enterprise software and cloud business
  • BS in Computer Science / Management Science / Engineering; MS Preferred
  • Experience as a software developer and/or data scientist supporting sales teams
  • Experience with scripting languages
  • Experience with cloud technologies / deployments
  • Experience working with Finance, Sales, and Marketing teams
  • Exposure to infrastructure planning, capacity planning
  • Exposure to metering, billing, payment, and financial systems
26

Project Lead / Principal Programmer Resume Examples & Samples

  • Communicate and negotiate programming timelines to Clinical Trials Teams
  • Ensure compliance with MedImmune standards and SAS custom data listings, summary tables, and figures as specified in statistical analysis plan/statistical programming plan
  • Lead development of robust, flexible SAS macro programs or modules that generate standard outputs and/or facilitate CDISC implementation
  • Provide technical leadership on MedImmune functional initiatives (i.e., CTR, CDISC Implementation, etc.)
  • Provide performance evaluation feedback for SAS programmers working on projects
  • Proactively interact directly with Biostatisticians, Data Management, Programmers, Clinical Development staff and management
  • Provide oversight for programming deliverables performed by MedImmune’s functional service provider
  • Lead the development and documentation of mapping specifications for creating analysis datasets
  • Implement standard and custom data listings, summary tables, and graphs as specified in statistical analysis plan for inclusion in the clinical study report. Responds to ad-hoc requests from the CTT
  • Develop robust, flexible SAS macro programs, modules and applications
  • Challenge conventional practices and creates/implements novel systems and procedures to enhance productivity and / or add new functionality
  • Assure the compliance of standards for self and other programmers assigned to projects
  • Review and provide feedback of case report form designs, eCRF annotations, dB structures, edit checks, SAPs and SPPs
  • Mentor and train programmers on MedImmune standards and practices as well as SAS technical skills
  • Consult with other project teams on implementing superior technical solutions
  • BA/BS with concentration in Life Sciences, Computer Science, Mathematics, Statistics or a quantitative/analytical field
  • Minimum 8 years of clinical trial programming experience using SAS within pharmaceutical, biotechnology, and/or contract research organization industries
  • Superior SAS programming skills with proficiency in Base SAS SAS/STAT and SAS/Graph
  • Thorough understanding of CDISC guidelines
  • Broad familiarity of FDA regulations and GCP/ICH guidelines as related to clinical trial SAS programming and reporting processes
  • A minimum of 10 years of clinical trial programming experience using SAS within the pharmaceutical, biotechnology, and/or contract research organization industries
  • Expert SAS programming skills with proficiency in Base SAS and its macro facility, SAS/STAT and SAS/GRAPH
  • Good working knowledge of FDA regulations and GCP/ICH guidelines as related to clinical programming processes
  • Excellent collaborative skills and the ability to manage complexity and change in a dynamic environment
  • Detail-oriented with sound judgment and flexibility. Advanced knowledge of project management and resource utilization skills
  • Ability to effectively work within and across functional teams and therapeutic areas in a global team environment
  • Good knowledge of project management, resource utilization, and negotiating skills
  • Robust knowledge of medical terminology and clinical research trials methodology
  • Exceptional analytic and critical thinking, writing, and communication skills
  • Ability to proactively managing expectations on timelines for SAS programming deliverables
  • Excellent organizational, analytical, and collaborative skills with the ability to manage complexity and change in a dynamic environment
  • Good knowledge of medical terminology and clinical trials methodology
27

Principal Programmer Resume Examples & Samples

  • Operating System Support and Maintenance
  • Coordinate test functions related to the most recently released version of the University's current administrative systems/applications
  • Oversee the delivery and modification of the existing application as necessary in accordance with the University's developing need(s)
  • Ensure that documentation on all modifications is created in accordance with established departmental procedures
  • Assist with the retrieval and installation of all related patches and upgrades
  • Work with System Administrators to optimize administrative application
  • Work with third party vendors as necessary to create and facilitate the interfacing of vendor hardware and software with application(s)
  • Programming Skills
  • Test latest releases in the development environment to ensure functionality of the delivered product
  • Modify existing administrative systems and applications with custom changes through use of the application (Ellucian Envision) tool kit, the UniBasic and SQL programming languages, and HTML and JAVA programming languages as required
  • User Support
  • Proactively work with end-users within the University community to assist and determine their varying needs and requirements by designing appropriate programs using the application's tool kit/programming language to meet those needs and requirements within the specified timeframe
  • Analyze and optimize applications to ensure their usefulness and effectiveness at the University
28

Senior Principal Programmer, Clinical Resume Examples & Samples

  • Serve as a lead programmer for compounds within a therapeutic area
  • Resolve problems as they arise within defined procedures and escalate if necessary at appropriate time
  • Negotiate, assess, and monitor project priorities/timelines
  • Review synopsis and/or protocol and provide comments for the Review Committee
  • Oversee creation of operational metadata (including CRF and external) and ensure compliant to Celgene standards
  • Lead the development and maintenance of clinical databases including data entry screens and edit checks in accordance with Celgene standards
  • Lead the development of external data transfer specifications based on Celgene standards
  • Lead the development and maintenance of data review listings in SAS and/or reporting tools for data review purposes
  • Support database lock activities and perform deliverables restriction
  • Ensure that all programming deliverables are compliant with CDISC and other Celgene programming standards
  • Provide clinical programming input into the SOW activities and review associated budget
  • Partner with CROs and act as a primary point of contact for clinical programming activities
  • Provide oversight of CRO/vendor programming activities to ensure adherence of standards as well as receiving quality and timely deliverables
  • Receive, process and review datasets, as well as data review reports from CROs
  • Ensure that programming best practices are adhered to by both CRO and Celgene programmers
  • Participate in study/project team meetings as a core member and provide technical expertise/support
  • Ensures that flexible and rapid responses are provided for programming requests
  • Monitor projects to ensure that SOPs are properly followed and documentation is available
  • BA/BS degree or equivalent in a relevant scientific discipline with a minimum of 7 years of experience as a Clinical Programmer or Database Programmer, as well as medical or mathematics/computer science background
  • Experience as a Lead Programmer overseeing the activities of support programmers as well as CRO/external vendors
  • Strong project management skills; good communication skills; ability to work in a cross-functional team environment
  • Experience with CDSIC standards including CDASH or SDTM/ADaM
  • Thorough understanding of clinical data structures, relational database structures, and data exchange with alternate data formats
  • Advanced knowledge of Clinical Database Design (Inform, Oracle Clinical, Rave or other systems) and associated programming procedures/process
  • Experience managing Rave Global Library is preferred
  • Knowledge of clinical study design. Detailed knowledge and experience in CRF design, central laboratories, programming databases, query resolution, data validation
  • Demonstrates expertise in the handling and processing of upstream data including multiple data sources, data workflow, and eDC
  • Proficient in SAS or SQL programming and conversion procedures (including extract, transform and load), as well as reporting tools (e.g. JReview, SpotFire)
  • In-depth knowledge of FDA/ICH guidelines, industry/technology standard practices and good programming practices
  • In depth understanding of regulatory, industry, and technology standards and requirements
  • In depth understanding of clinical terminology, clinical tests, medical terminology, and protocol designs
  • Demonstrate ability to work in a team environment with clinical team members
  • Excellent communication skills, excellent written, verbal, interpersonal and organizational skills
  • Excellent planning and project management skills as well as vendor management
29

Principal Programmer, Clinical Resume Examples & Samples

  • Advanced knowledge of Clinical Database Design systems is a must. Ability to take full advantage of all of applicable procedures and processes available in RAVE, Oracle Clinical and/or Inform (Central Designer)
  • 1 year of experience in RAVE is preferred
  • Good communication skills; ability to work in a team environment with medical personnel, clinical monitors, statisticians, programmers, and medical writers
  • Knowledge of SQL programming
  • Computer skills: detailed knowledge of Oracle Clinical and/or Inform (Central Designer), proficiency with SAS data sets and conversion procedures, knowledge of MS Office program suite
  • Experience managing clinical programmers a plus
  • Knowledge of clinical trial design and basic statistics a plus
30

Senior Principal Programmer Resume Examples & Samples

  • Lead the development of department or cross-functional SOPs, Working Practices and best practices for the department related to the Library Capability
  • Support cross functional initiatives and ensure that DCR change management is implemented for Library related activities
  • Provide guidance for resolving Library capability concerns raised
  • Work with cross functional team to approve and execute process updates to Library
  • Liaison with the standard governance organization roles like Project Standards Manager and Global Standards Manager to maintain alignment with the business and proactively look for opportunities to build efficiencies
  • BA/BS in a relevant scientific discipline
  • 5-7 years Pharmaceutical/CRO experience as a clinical programmer supporting clinical trials for regulatory submissions
  • Expert knowledge or certified in the Medidata product Rave is required. Global Library, Safety Gateway, Coder and Patient Cloud knowledge is highly desirable
  • Demonstrated ability in the handling and processing of upstream data, e.g., multiple data forms, workflow, eDC, SDTM
  • Demonstrated ability in providing outputs to meet downstream requirements, e.g., ADaM, Data Definition Table, e-submission