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Associate Director, Statistical Programming

Revolution Medicines

Redwood City, CA, US
  • Job Type: Full-Time
  • Function: Product Mangement
  • Industry: Biotechnology
  • Post Date: 02/12/2024
  • Website: www.revmed.com
  • Company Address: 700 Saginaw Dr, Redwood City, California 94063, US

About Revolution Medicines

REVOLUTION Medicines discovers and develops new drugs that harness the therapeutic potential of frontier oncology targets on behalf of cancer patients.

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

The Opportunity:

Position requires at least 8 years of Statistical Programming experience with exploratory-stage oncology clinical trials, providing programming support and oversight of one or more clinical programs within Statistical Programming function. In addition to hands-on Programming, this position may require managing one or more team members and assisting in Programming infrastructure and process development, in addition to providing technical support and guidance during regulatory submissions while ensuring conformance to CDISC standards and submission guidelines.  This person will be required to collaborate closely with cross-functional teams to help enhance process efficiency and quality of statistical outputs. Title may vary based on candidate experience.

In this position, you will be responsible for the Company’s Statistical Programming function, specifically:

  • Provide management and oversight of statistical programming resources including FTEs, contractors and CROs (e.g., SDTM vendors, independent statistical analysis center for DMCs)

  • Provide timeline and resource forecasts for statistical programming deliverables.

  • Ensure quality and timely delivery of analysis for our clinical trials.

  • Collaborating with internal team members effectively to help develop/enhance/maintain global macros and processes.

  • Ensure accuracy of clinical trial results for internal and external audiences (e.g., regulatory authorities, academic community, and healthcare providers) via QC of documents with clinical data.

  • Ensure that the interpretation of data obtained from our clinical trials is accurate and the process conforms to the SOPs and Work Practice guidelines.

  • Oversee Programming support for relevant deliverables, such as Investigator Brochures, publications, US, and ex-US regulatory submissions, including CDISC compliant datasets (SDTM, ADaM) and data documentation (Define.xml), Reviewer’s Guide (SDRG, ADRG), TLFs, Statistical Analysis Plans (study specific, ISS, ISE, Exposure-Response), CRF reviews.

  • Hands-on programming of in-house deliverables including but not limited to Dose Committee meetings, Board of Director meetings, Exploratory Analysis, etc.

  • Verification and review of documents, spreadsheets, slides for in-house presentations and external publications.

Specific required experience, skills, and education:

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

  • Hands-on experience in programming for early-stage clinical trials.

  • A demonstrable record of strong leadership and teamwork.

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

  • Effective, Customer Focused, Responsive, Accountable, and possesses excellent written and verbal communication skills.

  • Demonstrated ability to multi-task, prioritize options, anticipate challenges, and execute is extremely important.

  • Industry experience is essential.

Revolution Medicines currently requires that all personnel and visitors to its offices be fully vaccinated against COVID-19. This role will require that the employee meet with company employees and work from the company’s offices. Given that these essential functions of the role must be performed on-site, this position requires full COVID-19 vaccination, subject to applicable law.

The expected salary range for this role is $175,000 - $210,000. An individual’s position within the range may be influenced by multiple factors, including skills and experience in role, overall performance, individual impact and contributions, tenure, and market dynamics. 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.

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