Revolution Medicines is seeking a lead statistician to provide statistical leadership and support for clinical development strategy and clinical studies through product life cycle, specifically for oncology trials.
Requirements
- Hands-on experience in design and analysis of oncology trials is a must.
- Proficiency in SAS and/or R.
Responsibilities
- Provide statistical support and strategic input to clinical development plans and target product profiles, proof of concept criteria, and team’s preparation for company governance reviews.
- Represent Biostatistics function on cross-function teams at program level and serve as a lead statistician for oncology studies.
- Collaborate with various functions on study design and planning, protocol development, statistical analysis plan and analysis specifications.
- Provide statistical support for study protocol development, analysis plan and specification through direct involvement and/or providing guidance to junior staff.
- Plan and prepare independent data monitoring committee (DMC), coordinate with independent statistical data analysis center for DMC and study team for periodic DMC reviews.
- Collaborate with data management and clinical operations over the course of clinical studies to provide statistical input to study conducts and database development as well as data collection and cleaning activities.
- Collaborate with statistical programming to ensure that appropriate programs and documentations are being developed for datasets development and outputs generation, and ensure the statistical analyses specified in scientific protocols and/or analysis plans are conducted appropriately.
Other
- Ability to work independently and within a team.
- Solid knowledge in ICH and other regulatory requirements related to biostatistical activities and clinical trials.
- Excellent verbal and written communication skills are required.
- Good interpersonal and project management skills are essential.
- Ph.D. or M.S. in Statistics/Biostatistics, a minimum of 8 years (for Ph.D.) and 12 years (for M.S.) of experience in the biotech/pharma industry as a statistician.
