Biostatistician Job Description
Biostatistician Duties & Responsibilities
To write an effective biostatistician job description, begin by listing detailed duties, responsibilities and expectations. We have included biostatistician job description templates that you can modify and use.
Sample responsibilities for this position include:
Biostatistician Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Biostatistician
List any licenses or certifications required by the position: SAS, CITI, WPP
Education for Biostatistician
Typically a job would require a certain level of education.
Employers hiring for the biostatistician job most commonly would prefer for their future employee to have a relevant degree such as Master's and Bachelor's Degree in Biostatistics, Statistics, Writing, Education, Epidemiology, Public Health, Graduate, Computer Science, Applied Mathematics, Communication
Skills for Biostatistician
Desired skills for biostatistician include:
Desired experience for biostatistician includes:
Biostatistician Examples
Biostatistician Job Description
- Working on protocols, statistical analysis plans (SAPs), CRF design, and study initiations
- Supporting statistical activities for Phase III program from study design, protocol development, SAP development, study initiation, validating analysis data sets and TLGs
- Perform SAS programming to meet the needs of clinical trials as defined in the SAP
- Works with the medical director, the regulatory lead and other clinical operations staff on the project team on clinical development plans
- May participate on project teams as the lead biostatistician on multi-protocol projects within a therapeutic area
- Communicates with study team members regarding study execution as it relates to timelines, data quality, and interpretation of results
- Design clinical studies
- Write and review statistical sections and other relevant parts of study synopses and protocols
- Support study start up activities
- Develop RAP, program TLFs, preparation for database lock, dry run and CSR activities
- Ability to promote teamwork in a multi-disciplinary team setting
- Coordinate study tasks with other statisticians and other line functions
- Ensure timeliness and adequate quality of statistical deliverables
- Providing consultation on statistical methods
- Master’s degree in statistics, biostatistics public health or related field
- Ensure timeliness and adequate quality of all bio statistical deliverables for the assigned trials
Biostatistician Job Description
- Propose and evaluate the performance of statistical methods in order to prepare statistical analysis plans
- Write and execute SAS programs to analyze the data and to report results creating tables and standard listings
- Perform statistical analysis, run simulations and discuss with internal and external experts
- Process and adhere to company and project-specific standards
- Reviews project protocols, authors protocol statistical
- Reviews protocols and case report forms for soundness of trial design
- Supports creation of publication material from a statistical perspective
- Performs complex statistical analyses, interprets statistical results and helps prepare study reports including summaries for FDA submissions
- Assists with clinical study design and protocol amendments
- Performs relevant sample size calculations
- Understanding of ICH GCP general knowledge of industry practices and standards
- Interacts directly and independently with client to coordinate all facets of the project
- Has high level knowledge of drug development as it pertains to biostatistics
- Strong resource for biostatistics
- Works with programming team to provide definitions, documentation, and review of derived variables needed to produce planned tables, listings, and graphs (TLGs)
- Develops data and programming specifications jointly with programmers
Biostatistician Job Description
- Knowledge and experience with CDC surveillance and case-control study design and analysis
- Thorough understanding of statistical methods including, but not limited to, linear, logistic, and conditional logistic regression models, survey statistics and survival analysis
- Authors or reviews statistical sections of clinical study reports
- Writes complex statistical plans, protocols and reports
- Provide statistical support to the CDC
- Support statistical needs of Clinical Research and other project teams
- Support clinical trial data management activities to include
- Plan and execute a range of biostatistical activities to support Clinical Development and Medical Affairs
- Oversee third party vendors as needed
- Perform ad hoc analyses of existing databases, meta-analyses, and data mining
- Assists in designing data presentations including summary tables, graphs, and subject listings
- Monitors data quality from a study conduct and output perspective
- Performs and/or coordinates and oversees the preparation, execution, reporting and documentation of all analyses (interim and final)
- Assists in writing efficacy sections of clinical study reports and summary documents with in-house medical writers and the client's study team
- Assumes responsibility for quality and statistical integrity of clinical study reports and summary documents
- Performs analyses and prepares data presentations for clinical registration dossiers based on strategies developed by the client
Biostatistician Job Description
- To develop SAP/AAR (involving sensitivity analysis to support robustness of result) and coordinate review
- To do the QC of the statistical analysis methodology
- To validate study specific dataset & analysis pgm specification
- To provide stat support to an independent analysis center
- Ensure the study design, monitoring, analysis will bring scientific information
- Develop and oversee complex statistical functions including the design and analysis of pre-clinical experiments, clinical trials, outcomes research, grant preparation, authoring scientific and clinical publications, and implementing complex statistical methodologies
- Be responsible for performing and interpreting statistical analysis on numerous clinical data sets, database management, and consultation on research
- Evaluate databases and statistical analysis programs and interact with computer groups to determine hardware/software compatibility
- Contribute to content and review of presentations and manuscripts
- Provide statistical support for the Diabetes area
- Conducts thorough self-reviews of own analyses prior to release to client
- Follows processes related to project management as appropriate for biostatistical projects
- Takes initiative to suggest and implement departmental process improvements
- Leads some projects with minimal management oversight, including complex projects with multiple team members and independent coordination with the client
- Complies with Document Control Procedure
- Complies with Record Control Procedure
Biostatistician Job Description
- Provide statistical collaboration and/or consultation to research scientists, investigators, database designers, and managers of WRAIR/NMRC and outside clients
- Assist in the development of formal experimental protocols subject to the Army, Navy, and Animal Welfare Regulations
- Assist in the development of the statistical portion of human protocols
- Apply a variety of biostatistical methods and tools
- Document critical reviews at an appropriate level for the intended audience
- Status report meeting with COR will occur on a weekly basis with Tuesday as the targeted day
- Products provided to the customers shall be free of obvious errors and consistent with statistical methods published in peer reviewed literatures
- Preparation of sections of statistical reports, input into Clinical Study Reports, under the supervision of senior statistical staff
- Display interpersonal and effective communication skills
- Be responsible for the statistical designs of clinical/epidemiological studies, creating statistical sections for study synopses and protocols
- Ensures compliance to applicable ISMS policies and procedures
- Oversees data management (auditing, editing & analysis) and quality control of study databases
- Participates in project development from beginning to end
- Work will be performed in an office environment with a low to moderate noise level
- Candidates must be a US citizen or permanent resident
- Candidates must be able to pass a Minimum Background Investigation