Statistical Project Lead

6 days ago


Menlo Park, California, United States Summit Therapeutics Sub, Inc. Full time

Job Summary

We are seeking a highly skilled Biostatistics Director to lead our clinical trials in oncology. As a key member of our team, you will provide strategic statistical and regulatory guidance to ensure project success.

About the Role

This is a challenging opportunity for a seasoned biostatistician to take on a leadership role in developing and executing statistical strategy, study design, and regulatory submissions for clinical trials in oncology.

Key Responsibilities

  • Provide technical leadership and statistical support to clinical development through the design and conduct of clinical studies in oncology.
  • Support/contribute to protocol development to ensure appropriateness of trial design, sample size, and propose the use of meaningful and efficient statistical methodologies.
  • Lead development of statistical analysis plans, data presentation plans, clinical development plans, and biometrics related submission activities.
  • Review the accuracy of clinical data, perform statistical analysis, interpret study results, and collaborate with clinical team and other team members to produce interim reports, final reports, and publications.
  • Represent biostatistics function or biometrics department in cross-functional teams.

Requirements

To be successful in this role, you will need:

  • A minimum of PhD 8+ or MS (11+ years of experience) in statistics or biostatistics or related disciplines with clinical trials, pharmaceutical/biotech industry, or healthcare experience.
  • Experience in supporting oncology phase II/III clinical studies.
  • Experience in organizing and driving regulatory submissions (e.g. NDA, sNDA, BLA).
  • In-depth knowledge of CDISC standards.
  • Technical expertise and knowledge of experimental design and analyses using SAS, R, or EAST, and etc.

What We Offer

At Summit Therapeutics Sub, Inc., we offer a competitive compensation package, including a salary range of $228,000 to $252,000 annually, bonus, stock, benefits, and/or other applicable variable compensation. You will also be eligible for health benefits, 401(k) with 6% employer match from day one, ESPP with up to a 15% discount up to the federal limit, flexible spending account among other benefits compensation.



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