Participates in the strategic discussion and study design for new indications/studies. Coordinates statistical analysis plans, and reporting (tables, listings, and figures) standards so that international submissions can be assembled efficiently with all studies acceptable to international regulatory agencies. Provides biometry support for investigator led studies.
- Serves as principal biometry contact to the clinical development department, providing inputs into clinical trial design and execution, coordinating statistical analysis, reporting, and interpreting the clinical trial results.
- Analyzes clinical trial data, producing accurate results representing the outcome of the trial. Validates statistical output. Interprets and clearly communicates statistical results and concepts
- Supervises the biostatistics work provided by CROs and independent consultants and reviews data management documents including, but not limited to, CRFs, data management plan, database specifications, and edit checks.
- Uses appropriate statistical methods to estimate the number of patients required for each potential study.
- Writes Statistical Analysis Plans; prepares for blinded data review meetings.
- Writes statistical analysis section of protocol and clinical study reports.
- Oversees the process of randomization schedule generation.
- Provides input into statistical SOPs and general standardization efforts within the clinical development department (e.g. statistical methodology standards, standard data presentations, standard CRFs).
- Supports Regulatory Authority meetings (e.g. pre IND meetings; Represents company at FDA or other agency with regard to methodological issues and support of results).
- Interacts with programmers to review programs and with the biometry team to achieve departmental goals.
- Expert knowledge of statistical methodology, including experimental design, linear models, categorical data techniques, nonparametric statistics, and survival analysis. Expert knowledge of developing advanced statistical and probability theory. Expert knowledge of FDA guidelines related to trial design, analysis, and reporting. Solid skills in computer programming (especially SAS). Strong communication and interpersonal skills. Excellent writing ability to author reports that will be acceptable to regulatory agencies. Strong analytical, problem-solving, and active learning skills. Strong organizational, documentation, and information gathering skills. Ability to work in multiple therapeutic indications and able to handle multiple projects across these therapeutic areas.
- Master's degree or PhD in statistics or related field.
- Typically requires 12 years of pharmaceutical experience. (If PhD in statistics, equivalency is 9 years of pharmaceutical experience.)
- Works on unique issues and assignments, exercising independent judgment in determining the appropriate means and methods. Exercises independent judgment in developing methods, techniques, and evaluation criteria for obtaining results.
- Acts independently to determine methods and procedures on new or special assignments. May act as
- Works on significant and unique issues where analysis of situations or data requires an evaluation of intangibles.
- Exercises independent judgment in methods, techniques and evaluation criteria for obtaining results.
- Creates formal networks involving coordination among groups.