Director, Biostatistics
Director, Biostatistics
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$ 204000 - 255000
1 Vacancy
Job Description
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 professionals in 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 program(s) and studies and the subject matter expert (SME) in Biostatistics within Quantitative Sciences function this position is to provide statistical leadership and support for clinical development strategy and clinical studies through product life cycle.
Provide statistical support and strategic input to clinical development plans and target product profiles proof of concept criteria and teams 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.
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 a minimum of 8 years (for Ph.D.) and 12 years (for M.S.) of experience in the biotech/pharma industry as a statistician. Level will be determined based on the relevance of experience.
Hands-on experience in design and analysis of oncology trials is a must.
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.
Proficiency in SAS and/or R.
Preferred Skills Experience and Education:
- Active participation in NDA/BLA filing through label negotiations desirable.
The base salary range for this full-time position is $204000 to $255000 for candidates working onsite at our headquarters in Redwood City CA. The range displayed on each job posting is intended to be the salary for an individual working onsite in Redwood City and will be adjusted for the local market a candidate is based in. Our salary ranges are determined by role level and location. Individual pay is determined by multiple factors including job-related skills experience market dynamics and relevant education or training.
Please note that base salary 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.
#LI-Hybrid #LI-SH1
Required Experience:
Director
Employment Type
Full Time
