Senior Director, Biostatistics – Late Phase
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Job Location:
Redwood City, CA - USA
Monthly Salary:
Not Disclosed
Posted on:
2 days ago
Vacancies:
1 Vacancy
Job Summary
Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The companys R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins and RAS Companion Inhibitors for use in combination treatment strategies. As a new member of the Revolution Medicines team you will join other outstanding Revolutionariesin a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.
The Opportunity:
Playing a critical role as a lead statistician for clinical Late-Stage program(s) and the subject matter expert (SME) in Biostatistics within Quantitative Sciences function this position is to serve as a program level lead statistician and provide statistical leadership and support for clinical development strategy and programs through product life cycle.
Lead strategic statistical thinking and contributions to clinical development plans.
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.
Provide statistical input and leadership to the development of global health authority documents regulatory interaction and response to health authority submissions.
Provide statistical support for clinical publications assist in data interpretation to ensure consistency and accuracy in data presentation.
Drive and lead department initiatives best practices and guidelines.
Keep abreast in new developments in statistics drug development and regulatory guidance and share knowledge with functional and cross-functional team members.
Required Skills Experience and Education:
Ph.D. or M.S. in Statistics/Biostatistics minimum 10 years (for Ph.D.) and 14 years (for M.S.) of experience in biotech/pharma industry as a statistician. Level will be determined based on the relevance of experience.
Extensive experience in design and conduct of phase 3 oncology trials.
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.
Proficiency in SAS and/or R.
Preferred Skills:
Experience with lead role in NDA/BLA filing desirable.
#LI-Hybrid #LI-SH1
The base pay salary range for this full-time position for candidates working onsite at our headquarters in Redwood City CA is listed below. The range displayed on each job posting is intended to be the base pay salary range for an individual working onsite in Redwood City and will be adjusted for the local market a candidate is based in. Our base pay salary ranges are determined by role level and location. Individual base pay salary is determined by multiple factors including job-related skills experience market dynamics and relevant education or training.
Please note that base pay salary range is one part of the overall total rewards program at RevMed which includes competitive cash compensation robust equity awards strong benefits and significant learning and development opportunities.
Revolution Medicines is an equal opportunity employer and prohibits unlawful discrimination based on race color religion gender sexual orientation gender identity/expression national origin/ancestry age disability marital status medical condition and veteran status.
Revolution Medicines takes protection and security of personal data very seriously and respects your right to privacy while using our website and when contacting us by email or phone. We will only collect process and use any personal data that you provide to us in accordance with ourCCPA additional information please contact.
We are aware of recent recruitment scams in which individuals or organizations falsely represent themselves as being affiliated with Revolution Medicines. These scams may appear as false job advertisements or unsolicited contacts through communication or chat platforms email phone or text message.
Please note that Revolution Medicines does not extend unsolicited employment offers and will never ask candidates to provide financial information purchase equipment or pay fees as part of the hiring process. All legitimate communication from Revolution Medicines will come from an official @ email address.
If you believe youve been contacted by someone impersonating a Revolution Medicines recruiter please report it to so we can share these impersonations with our IT team for tracking and awareness.
Required Experience:
Exec
Key Skills
- FDA Regulations
- Management Experience
- Manufacturing & Controls
- Biotechnology
- Clinical Development
- Clinical Trials
- Drug Discovery
- Project Management
- Filing
- Team Management
- Leadership Experience
- Chemistry
