Address
Form of workResponsibilities:
Requirements:
- Responsible for protocol development including study design, sample size calculation, randomization, and statistical analysis plan for assigned studies.
- Provide statistical oversight to studies and assure adequate quality and consistency with project requirements.
- Responsible for assuring that data for statistical analyses are complete, accurate and consistent.
- Responsible for statistical analysis plans and the accuracy and timeliness of statistical input into reports or decisions.
- Responsible for validity of analysis and explore alternative analysis strategies as needed.
Requirements:
- 4+ years' experience preferred leading late phase studies.
- MS or PhD in Statistics, Biostatistics or related field. PhD with 3-5 years of experience or MS with 6-8 years of experience.
- Must have experience in AdAM.
- Strong oral and written communications skills, with ability to effectively communicate internally and with clients.
- Infectious disease background + experience working on observational studies.
- Pharmaceutical, CRO, or related industry experience with clinical trials, including interaction with Regulatory Agencies, especially FDA
