Director, Statistical Programming

Revolution Medicines • Redwood City, CA

6d • $211,000 - $264,000 • Hybrid

About The Position

Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The company’s 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 Revolutionaries in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.
The Opportunity:
Position requires at least 15+ years of Statistical Programming experience with early and late-phase oncology clinical trials, leadership, and oversight of one or more clinical programs within Statistical Programming function. This position will require managing programming resources, assisting in establishment, development and oversight of Programming infrastructure and process, providing technical support and guidance for regulatory submissions including ISS/ISE, SCS/SCE while adhering to CDISC standards and submission requirements. This person will be required to collaborate closely with cross-functional teams to help drive and adhere to major submission deliverable timelines. Titles may vary based on candidate experience.

Requirements

• MS, BS/BA degree, or other suitable qualification with relevance to the field.
• 15 or more years’ direct experience of designing and running early-stage or late-stage clinical trials.
• MS, BS/BA degree, or other suitable qualification with relevance to the field.
• Firsthand experience in leading, managing teams in late-phase clinical trials.
• A demonstrable record of strong leadership and teamwork.
• Proven experience in developing and leading high-performing teams.
• Familiarity with ICH guidelines and other regulatory requirements.
• Thrives in a collaborative team setting and is driven by a desire to deploy innovative approaches and technologies in a high energy environment.
• Effective, Client-driven, Responsive, Accountable, and possess excellent written and verbal communication skills.
• Demonstrated ability to multi-task, prioritize options, anticipate challenges, identify and resolve issues and positively influence the team.

Nice To Haves

• Oncology experience, especially in solid tumors.
• 5 or more years’ direct line management experience.

Responsibilities

• Provide management of statistical programming resources including FTEs, contractors and CROs involved in early or late-phase studies.
• Ensure quality and timely delivery of analysis for our clinical trials.
• Ensure accuracy of clinical trial results for submission and submission related deliverables.
• Firsthand programming, if required, of critical ADAMs and TLFs that form a part of regulatory submissions.
• Verification and review of submission related documents, including vendor SOPs, work instructions and other processes related to submission requirements.
• Leading efforts to establish, develop and maintain programming infrastructure activities.

What This Job Offers

• Job Type: Full-time
• Career Level: Director