Associate Director Statistics
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Associate Director StatisticsApply Now
Provide statistical oversight for multiple marketed products, while collaborating with clinical science, drug safety, regulatory, and other R&D functions in the strategic management of marketed products.
Candidate expectations include the following:
- Independently manage the statistical aspects of clinical studies including: study protocol design, SAP, management of statistical deliverable, writing of study report.
- Provide oversight of statistical work performed by contract clinical research organizations.
- Experience leading NDA/SNDA (or similar) submission including product labeling.
- Experience interacting with and responding to regulatory agencies (e.g. FDA).
- Proficiency with interacting with clinical scientist for data interpretation and product strategy.
- A strong understanding of the overall drug development process and flexibility to work on multiple different projects simultaneously.
- Good analytical and problem solving skills.
- Proficient in statistical programming with SAS.
- Knowledge of FDA, EMA and ICH regulations and guidelines.
- Masters degree in Statistics with 8+ years experience or PhD degree in Statistics with 5+ years experience.
Job ID R0022748