The Biostatistician is responsible for ensuring the plan and conduct of high quality, compliant, and efficient clinical research and data analysis by collaborating with clinical operations, clinical research, database programming, and medical writing teams. The Biostatistician will also provide statistical support for research and development and quality assurance programs.
- The Biostatistician will report directly to the VP, Clinical Research & Medical Affairs.
Essential Duties and Responsibilities
- Together with the VP, Clinical Research & Medical Affairs, develop statistical input for protocol development, study design, and case report form development by actively contributing to study design considerations.
- Perform/oversee production and quality control of randomization schedules, statistical analysis plans, statistical reports, statistical sections of integrated clinical reports and other process supporting documents.
- Perform/coordinate the production of statistical outputs for various analysis and reporting purposes, and provide statistical review and program validation for each project to ensure the integrity, adequacy and accuracy of the outputs.
- Perform sample size calculations and write statistical methodology sections for inclusion in study protocols.
- Design statistical analysis plans and table shells in accordance with study protocols or for integrated efficacy and safety summaries for New Drug Application (NDA) submissions.
- Develop, test, maintain and archive SAS program code to perform statistical analysis and generate analysis datasets and statistical reports of clinical data.
- Design analysis file specifications in accordance with the statistical analysis plan and table shells, and CDISC ADaM standards if applicable.
- Perform statistical QC review of source code and output developed by other CRO biostatisticians for statistical reports.
- Provide statistical input for Data Safety Monitoring Committee (DSMC) activities, including development of DSMC charters and analysis plans. Prepare statistical data packages for scheduled and ad hoc DMSC meetings as required across all clinical programs.
- Understand regulatory requirements related to the specific therapeutic areas and the implications for statistical methodology and analysis.
- Manage CROs in regard to statistical work; including identifying suitable partners, defining CRO responsibilities, and maintaining interactive management.
- Perform statistical review of clinical data and communicate data issues to data management and clinical trial and research managers.
- Provide statistical insight in the interpretation and discussion of study results and provide statistical contribution to the integrated clinical study reports and publications.
- Assist with regulatory filings, including drafting, editing and preparing of routine correspondence and sections of INDs, BLAs, NDAs, Annual Reports, Amendments, Supplements, Orphan Drug Applications and other regulatory submissions.
- Oversee development and maintenance of biostatistical SOPs.
- Provide statistical support for the design and analysis of nonclinical research and development studies and quality assurance programs.
- Keep management abreast of issues and progress on all assigned projects.
- Other duties as assigned
- M.S. in biostatistics, mathematics or statistics; an undergraduate degree in a health sciences field is preferred. PhD degree is preferred.
- The ideal candidate will have experience in ophthalmology and/or rare disease clinical trial design and data analysis.
- At least five (5) years of experience in statistical analysis of clinical trials data, general linear models, mixed models, survival analysis, categorical data analysis and non-parametric methods.
- CRO statistics vendor oversight a plus
- Proficiency in SAS statistical programming including understanding of macros.
- Knowledge of other statistical and data management software packages is a plus.
- Knowledge and experience with CDISC data standards and models.
- Demonstrated in-depth understanding of GCP and FDA IND regulations.
- Demonstrated ability to design and conduct statistical analyses in clinical research activities.
- Effective written and oral communication abilities.
- Strong interpersonal, negotiating and problem-solving skills.
- Ability to effectively manage multiple tasks and projects.
- Innate collaborative attitude, with demonstrated ability to work effectively in a small company environment.
- Previous management or supervisory experience is not required.
- This position has no direct reports.