Associate Director, Statistical Programming (Menlo Park) Job at Summit Therapeutics, Inc., Menlo Park, CA

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  • Summit Therapeutics, Inc.
  • Menlo Park, CA

Job Description

Associate Director, Statistical Programming

4 hours ago Be among the first 25 applicants

Job Title: Associate Director, Statistical Programming
Location: Menlo Park, CA or Miami, FL ONSITE

Overview of Role

The Associate Director, Statistical Programming will lead and manage statistical programming activities for clinical trial data collection, analysis, reporting, and visualization, primarily focusing on oncology studies. This role involves developing and implementing strategies, managing a team of programmers, and collaborating with cross-functional teams to ensure high-quality, regulatory-compliant deliverables that support drug development.

Responsibilities include:

  • Managing and mentoring statistical programmers.
  • Developing and executing programming strategies aligned with industry standards and regulations.
  • Overseeing creation and validation of CDISC-compliant datasets, especially oncology-specific endpoints.
  • Collaborating on complex statistical analyses for oncology trials.
  • Leading the development of TLFs for reports and regulatory submissions.
  • Ensuring compliance with FDA, EMA, PMDA, and other agencies.
  • Standardizing oncology analysis datasets and macros for efficiency.
  • Managing resources, timelines, and external vendors.
  • Representing statistical programming in cross-functional and regulatory meetings.
  • Contributing to SOPs, quality control, and staying current with industry trends.

Qualifications:

  • Master's in Statistics, Biostatistics, Computer Science, or related field.
  • At least 12 years in statistical programming, with 5+ in oncology and leadership roles.
  • Expertise in CDISC standards and SAS programming.
  • Knowledge of oncology endpoints and regulatory requirements.
  • Experience with regulatory documents and team management.
  • Proficiency in R and Python is desirable.

Preferred Qualifications:

  • Experience with immunotherapy trials and efficacy endpoints.
  • Knowledge of EDC systems, data visualization tools, and cloud computing.
  • Active in industry conferences and groups.

The salary range is $153,000 - $180,000 annually, with additional benefits. Summit does not accept external referrals without prior authorization.

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Job Tags

Full time,

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