Director, Statistical Programming

Revolution MedicinesSan Francisco, CA, US

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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 professionals in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.

The Opportunity :

This position will require overseeing one or more teams or disciplines within the Statistical Programming Team, and will be involved in the longterm process and functional strategy planning that will involve collaborating with multiple cross functional teams to ensure high-quality statistical deliverables that meet regulatory requirements and support drug development efforts. Additionally, this position will provide technical support and guidance for regulatory submissions including ISS / ISE, SCS / SCE while adhering to CDISC standards and submission requirements.

Management and oversight of one or more statistical programming teams and direct the activities of one or more stastical programming disciplines ensuring the integrity and precision of data-driven insights guiding our drug development efforts.
Involved in multiple cross functional interaction and collaboration to drive functional goals including submission requirements and processes.
Manage multiple studies / programs within early / late phase studies for Statistical Programming function.
Provide technical support and guidance for regulatory submissions including ISS / ISE, SCS / SCE while adhering to CDISC standards (SDTMs, ADaMs, define.xml) and submission requirements, to conform to submission standards (e.g., FDA 21 CFR Part 11, GxP)
Lead a team of statistical programmers including FTEs, contractors and CROs / programming vendors involved in early or late-phase studies. Provide training, guidance, and support to team members, fostering their career growth and development.
Provide hands-on programming support, as needed, of critical ADAMs and TLFs that form a part of regulatory submissions.
Verify and review submission related documents, including vendor SOPs, work instructions and other processes related to submission .

Required Skills, Experience and Education :

Position requires at least 18+ 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.

MS, BS / BA degree or other suitable qualification with relevance to the field.

Proven ability to manage multiple projects simultaneously and experience working in a a growing organization, coordinating with external vendors and partners.

Ability to identify and implement innovative solutions to complex programming challenges and strong problem-solving skills focusing on process development.

Hands-on experience in leading, managing teams in early and 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.

Ability to operate in a collaborative team setting and is driven by a desire to deploy innovative approaches and technologies in a high energy environment.

Ability to effectively communicate and negotiate timelines with cross functional groups / leaders to effectively set expectations on timelines and processes.

Effective, Responsive, Accountable, and excellent written and verbal communication skills.

Demonstrated ability to multi-task, prioritize options, anticipate challenges, identify and resolve issues and positively influence the team.

Preferred Skills :

Experience leading efforts to establish, develop and maintain programming infrastructure activities.

Experience working in a small to mid sized biotech / pharma environment.

Experience collaborating on development of processes, SOPs and guidance documents for the Statistical Programming function.

The base salary range for this full-time position is $204,000 to $255,000 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 our CCPA Notice and Privacy Policy . For additional information, please contact privacy@revmed.com .

Seniority level

Director

Employment type

Full-time

Job function

Marketing, Public Relations, and Writing / Editing

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Director Programming • San Francisco, CA, US