Revolution Medicines is seeking an Executive Director of Biostatistics to provide strategic and technical leadership for late-phase oncology clinical trials, aiming to advance their pipeline of novel targeted therapies for RAS-addicted cancers.
Requirements
- Proficiency in SAS and/or R.
Responsibilities
- Lead a biostatistics team for late-phase oncology programs, ensuring alignment with clinical development goals and regulatory requirements.
- Lead biostatistical strategy development for pivotal phase II/III trials, including adaptive designs and registration enabling trials.
- Partner closely with other subfunctions within quantitative sciences and with cross-functional teams, including clinical development, statistical programming, and regulatory affairs, to integrate statistical considerations into clinical development plans.
- Lead biostatical activities for regulatory submissions.
- Develop and implement policies, standards, and procedures to ensure consistency and quality in statistical practices.
- Manage relationships with external partners, such as contract research organizations (CROs), ensuring adherence to timelines, budgets, and quality standards.
Other
- D. or M.S. in Statistics/Biostatistics, a minimum of 15 years (for Ph.D.) and 17 years (for M.S.) of experience in biotech/pharma industry as a statistician, with at least 8 years in a leadership role within late-phase oncology Biostatistics.
- Successful direct experience with FDA, EMA and PMDA interactions including regulatory meetings and response to agency questions.
- Proven track record with successful regulatory submissions (NDA/MAA/J-DNA) to FDA, EMA, and PMDA.
- Proven ability to influence cross-functional teams, drive strategic initiatives, and mentor statistical talent.
- Solid knowledge in ICH and other regulatory requirements related to biostatistical activities and clinical trials.
- Strong communication skills with ability to present complex statistical concepts to diverse audiences.
- Excellent interpersonal and project management skills are essential.
