Manager, Biostatistics Cover Letter

Please consider me for the manager, biostatistics opportunity. I am including my resume that lists my qualifications and experience.

Previously, I was responsible for statistical expertise and input to drug development programs, including the design of translational research / biomarker analysis plans, and analyses requiring advanced statistical methodologies.

Please consider my qualifications and experience:

• Experience with hospital patient information data, such as Meditech data, is preferred
• Excellent knowledge of SAS programming and statistical analyses
• Experience with developing and reporting clinical research project plans, specifications, schedules, and technical parameters to management
• Excellent influence and leadership skills, and a demonstrated record of strong collaborations with clinicians, pharmacometricians, clinical scientists, and other non-statisticians at Manager level
• Solid knowledge of statistical analysis methodologies, experimental and clinical trial design
• Experience with direct management of personnel preferred
• Demonstrate and interact with diplomacy and tact while maintaining appropriate assertiveness and persistence
• Expertise in statistical methods to support Medical Affairs including analysis using the clinical database for scientific meetings, publications, and internal decision-making (generally based on previously conducted randomized clinical trials)

Please consider me for the manager, biostatistics opportunity. I am including my resume that lists my qualifications and experience.

Previously, I was responsible for biostatistics/statistical support for the clinical group engaged in Early Development of oncology programs/drug projects, the span of which ranges from clinical trials to world-wide regulatory application submissions and post marketing support.

Please consider my qualifications and experience:

• Experience interacting with Japanese regulatory agencies, in particular PMDA
• Communication skills in English for business needs
• Expert understanding and knowledge in statistical methodologies related to clinical trial designs, statistical modeling and data analyses
• Learns and follows all applicable SOPs, working practises and standards, and documents any deviations
• Member of professional organizations
• Some prior experience in applying statistical methods in biomedical research preferred
• Knowledge and skills in SAS and knowledge of other statistical software preferred
• Familiar with common statistical methods used in clinical research

I am excited to be applying for the position of manager, biostatistics. Please accept this letter and the attached resume as my interest in this position.

Previously, I was responsible for statistical expertise to maximizing the value of aggregate clinical data in support of scientific and drug development strategies.

Please consider my qualifications and experience:

• Expertise in statistical methods to support Health Economics and Outcomes Research including meta-analysis (including Bayesian network meta-analysis), patient reported outcomes (including development/validation), studies using external databases (claims, EMR), HTA/reimbursement/value dossiers, and real world studies
• Expertise in statistical methods to support new studies including randomized studies, observational (non-randomized) studies, registries, non-interventional studies, cluster randomization, pragmatic clinical trials
• Efficient statistical computing skills in SAS, R
• Understanding of statistical concepts and techniques, such as design of experiments, analysis of variance, linear and nonlinear regression, non-parametric methods, data mining, sample size calculations, variable selection, imputation techniques and high-dimensional data analysis
• Advanced theoretical knowledge of and direct experience with cancer treatment, biology, and prognosis or related field
• Demonstrated research abilities utilizing various resources to obtain information necessary to attain established objectives
• Familiar with research protocol (in order to follow protocols to screen patients for eligibility, initiate treatment plan, collect specimens, and orient participating physicians)
• Experience in interpreting technical data for written and oral presentation to the general public, cancer researchers, and medical community

In response to your job posting for manager, biostatistics, I am including this letter and my resume for your review.

Previously, I was responsible for administrative support to the Biostatistics SAS Programming and data manager for day to day operation as well as individual projects as needed.

I reviewed the requirements of the job opening and I believe my candidacy is an excellent fit for this position. Some of the key requirements that I have extensive experience with include:

• Experience in planning, scheduling and organizing meeting and conferences, including teleconferences
• Provide scientifically rigorous statistical expertise and contributions by working effectively within the
• Track record of high quality publications in peer-reviewed journals preferred
• In-depth knowledge of CRO Biostatistics environment
• Designing, analyzing and reporting of Japanese clinical trials within pharmaceutical / biotechnology / public health setting in industry, academia
• Experience of working with global team members
• Knowledge of life cycle drug development (pre-clinical development, clinical development, and post-marketing)
• Statistical contributions to regulatory submissions in Japan

Please consider me for the manager, biostatistics opportunity. I am including my resume that lists my qualifications and experience.

Previously, I was responsible for statistical expertise and input to drug development programs and safety surveillance including the design of clinical development plans, studies, and analyses requiring advanced statistical methodologies.

Please consider my experience and qualifications for this position:

• Good analytical and organizational abilities
• Good interpersonal skills to effectively work in cross-functional study teams
• Proficient in SAS programming related to dataset manipulation and the above statistical methods
• Keeps abreast of new developments in statistics and regulatory guidance
• Expertise and some practical experience in use of advanced statistical methodologies, especially with application to clinical trial design and analysis
• Working knowledge of regulatory guidelines for drug development, NDA submissions, and statistical practices, , CTD guidance, ICH guidelines
• Basic understanding of key clinical and regulatory concepts, endpoints, and trial designs in therapeutic areas / indications
• Familiarity with design, production, and use of submission-quality electronic datasets