Revolution Medicines
Director, Biostatistics
Revolution Medicines, San Francisco, California, United States, 94199
Overview
Director, Biostatistics at Revolution Medicines. Join Revolution Medicines, a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The R&D pipeline includes RAS(ON) Inhibitors and RAS Companion Inhibitors for combination strategies. As a member of the Quantitative Sciences function, you will provide statistical leadership and support for clinical development strategy and studies across the product life cycle. Responsibilities
Provide statistical support and strategic input to clinical development plans and target product profiles, proof of concept criteria, and team preparation for company governance reviews. Represent Biostatistics on cross-functional teams at the program level and serve as a lead statistician for oncology studies. Collaborate with study teams on study design and planning, protocol development, statistical analysis plans and analysis specifications. Provide statistical support for study protocol development and analysis plans, through direct involvement and/or guidance to junior staff. Plan and prepare independent data monitoring committee (DMC) activities, coordinate with the independent statistical data analysis center for DMC reviews. Collaborate with data management and clinical operations to provide statistical input to study conduct, database development, data collection and cleaning. Collaborate with statistical programming to ensure appropriate programs and documentation are developed for data set development and outputs, and that analyses are conducted as specified in protocols/plans. Provide statistical input and leadership to global health authority documents, regulatory interactions, and responses to submissions. Provide statistical support for clinical publications and assist in data interpretation to ensure accuracy in data presentation. Drive and lead departmental initiatives, best practices, and guidelines; keep abreast of new developments in statistics, drug development, and regulatory guidance. Qualifications
Ph.D. or M.S. in Statistics/Biostatistics; minimum 8 years (Ph.D.) or 12 years (M.S.) of biotech/pharma biostatistics experience. Level based on relevance of experience. Hands-on experience in design and analysis of oncology trials. Ability to work independently and within a team. Strong knowledge of ICH and other regulatory requirements related to biostatistics and clinical trials. Excellent verbal and written communication skills; strong interpersonal and project management abilities. Proficiency in SAS and/or R. Preferred Skills
Active participation in NDA/BLA filing through label negotiations is desirable. Compensation and Benefits
The base pay salary range for this full-time position for candidates onsite at our Redwood City, CA headquarters is $204,000 — $255,000 USD. The base pay is one part of an overall total rewards program including equity, benefits, and development opportunities. Salary is determined by role, level, location, market dynamics, and relevant qualifications and experience. 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 seriously and respects privacy in accordance with our CCPA Notice and Privacy Policy. For more information, contact privacy@revmed.com. Job Details
Location: Redwood City, CA or onsite
#J-18808-Ljbffr
Director, Biostatistics at Revolution Medicines. Join Revolution Medicines, a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The R&D pipeline includes RAS(ON) Inhibitors and RAS Companion Inhibitors for combination strategies. As a member of the Quantitative Sciences function, you will provide statistical leadership and support for clinical development strategy and studies across the product life cycle. Responsibilities
Provide statistical support and strategic input to clinical development plans and target product profiles, proof of concept criteria, and team preparation for company governance reviews. Represent Biostatistics on cross-functional teams at the program level and serve as a lead statistician for oncology studies. Collaborate with study teams on study design and planning, protocol development, statistical analysis plans and analysis specifications. Provide statistical support for study protocol development and analysis plans, through direct involvement and/or guidance to junior staff. Plan and prepare independent data monitoring committee (DMC) activities, coordinate with the independent statistical data analysis center for DMC reviews. Collaborate with data management and clinical operations to provide statistical input to study conduct, database development, data collection and cleaning. Collaborate with statistical programming to ensure appropriate programs and documentation are developed for data set development and outputs, and that analyses are conducted as specified in protocols/plans. Provide statistical input and leadership to global health authority documents, regulatory interactions, and responses to submissions. Provide statistical support for clinical publications and assist in data interpretation to ensure accuracy in data presentation. Drive and lead departmental initiatives, best practices, and guidelines; keep abreast of new developments in statistics, drug development, and regulatory guidance. Qualifications
Ph.D. or M.S. in Statistics/Biostatistics; minimum 8 years (Ph.D.) or 12 years (M.S.) of biotech/pharma biostatistics experience. Level based on relevance of experience. Hands-on experience in design and analysis of oncology trials. Ability to work independently and within a team. Strong knowledge of ICH and other regulatory requirements related to biostatistics and clinical trials. Excellent verbal and written communication skills; strong interpersonal and project management abilities. Proficiency in SAS and/or R. Preferred Skills
Active participation in NDA/BLA filing through label negotiations is desirable. Compensation and Benefits
The base pay salary range for this full-time position for candidates onsite at our Redwood City, CA headquarters is $204,000 — $255,000 USD. The base pay is one part of an overall total rewards program including equity, benefits, and development opportunities. Salary is determined by role, level, location, market dynamics, and relevant qualifications and experience. 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 seriously and respects privacy in accordance with our CCPA Notice and Privacy Policy. For more information, contact privacy@revmed.com. Job Details
Location: Redwood City, CA or onsite
#J-18808-Ljbffr