Provide statistical expertise to clinical stage project teams and research projects. Provide statistical consulting and technical support as it relates to the design and statistical analysis of clinical studies. Review, edit, or work with external vendor to develop analysis and data presentation specifications for SAS programming. Perform analysis, interpret study results. Work with and/or provide guidance as needed to other statisticians and bioinformatics personnel from other Departments.
- Functions as the point of contact for Clinical Contract Research Organizations that conduct and/or provide data management and statistical support for clinical programs.
- Provides statistical consultation for pre-clinical and clinical programs, including but not limited to protocol development, randomization, sample size assessments, efficacy evaluations, and data review.
- Responsible for oversight of the creation and implementation of statistical analysis plans for clinical and research protocols.
- Provides input to project timelines, and ensures that project timelines for biostatistics deliverables are met for internal and external communication.
- Ensures the accurate programming of SAS clinical data extracts and data displays.
- Reviews and provides comments on statistical summaries and analysis plans to ensure the accuracy of the statistical analysis summary and analysis plans, including textual description of planned analysis and mock-ups of data displays.
- Develops programming specifications to summarize the results of clinical trials, including analysis datasets and tables/listings/figures.
- Performs ad hoc statistical analyses for internal and external communication, including hypothesis testing and modeling.
- Provides tabular and written summaries of analyses and statistical methodology for Clinical Study Reports.
- Interacts with Medical Writers to ensure accurate description and appropriateness of data interpretation.
- Writes pertinent sections of a clinical study report
- Interfaces with regulatory agencies as the project biostatistician.
- Familiarity with statistical methods commonly used in the analysis of data obtained from Phase I – IV clinical trials.
- Experience with SAS Base and SAS Stat, as well as strong data step skills.
- Experience with other statistical software packages, such as R or S-Plus.
- Ability to work creatively and independently to carry out assignments of a complex nature.
- Ability to work effectively and cooperatively with other professional staff members.
- Ability to communicate effectively, both verbally and in writing, to explain statistical strategy and results of analyses.
Education & Experience Requirements
- M.S. in Biostatistics or closely related is required.
- Ph.D. in Biostatistics or closely related field is preferred.
- Generally 5+ years of relevant pharmaceutical experience.