Full-time

Gilead Sciences, Inc. is hiring a Manager, Statistical Programming

About the Role

Gilead Sciences is hiring a Manager, Statistical Programming to oversee the creation of Analysis Data Model (ADaM) datasets, Tables, Figures, and Listings (TFLs) for our clinical studies, ensuring they meet regulatory and quality standards. In this role, you'll serve as the Analysis Oversight Statistical Programming Lead, guiding programming strategy, monitoring vendor performance, and collaborating closely with the Study Management Team to influence key decisions.

What You'll Do

  • Exhibit strong statistical and programming expertise to influence key decisions and guide statistical programmers.
  • Review and approve statistical programming requirements and key study documents.
  • Communicate Study Management Team decisions and action items to the programming team.
  • Analyze vendor performance through Key Performance and Quality Indicators and participate in governance discussions.
  • Ensure adequate programming resourcing, assign tasks, and monitor activities within the task management system.
  • Perform quality checks to ensure deliverables are complete, accurate, and comply with Gilead and CDISC standards.
  • Lead analysis team meetings with Biostatisticians and serve as the point-of-contact with vendors.
  • Coach and mentor programming colleagues, provide statistical guidance, and support talent development.
  • Ensure the programming team identifies and resolves data issues prior to final production release.
  • Model inclusion, empower teams, and help connect team goals to organizational objectives.

What We're Looking For

  • A BS degree in Biostatistics, Computer Science, or equivalent with 6+ years of experience OR an MS degree with 4+ years of experience OR a PhD with 0+ years of experience.
  • Experience leading late-phase HIV studies in the Virology therapeutic area.
  • Mature statistical knowledge and expertise in developing ADaM and TFLs.
  • Proven track record delivering high-quality statistical programming datasets and outputs.
  • Deep knowledge of GCP, ICH guidelines, and regulatory requirements.
  • Ability to collaborate effectively with global team members across various time zones.
  • Excellent customer-focus with strong communication, coaching, and mentoring skills.
  • Strong experience in data analysis, critical thinking, and problem-solving using data-driven approaches.
  • Ability to motivate large, diverse teams and lead effective cross-functional collaborations.

Team & Environment

You will be a member of the Study Management Team (SMT), working closely with the study team and leading the statistical programming team.

Benefits & Compensation

  • Compensation Range: $133,195.00 - $172,370.00
  • Company-sponsored medical, dental, vision, and life insurance plans.
  • Paid time off.
  • Discretionary annual bonus.
  • Discretionary stock-based long-term incentives.

Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences.

Required Skills
SASRCDISCSDTMADaMStatistical ProgrammingClinical TrialsRegulatory SubmissionsTeam LeadershipProject ManagementBiostatisticsGCPICH GuidelinesMacro DevelopmentProgramming Validation
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About company
Gilead Sciences, Inc.

Gilead Sciences tackles diseases such as HIV, viral hepatitis, COVID-19 and cancer, working relentlessly to develop therapies that help improve lives and ensure access across the globe.

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Posted 3 months ago