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Biostatistics Director

13-15 years
$187,500 – $266,000 annually.
10 June 19, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

 

Job Title: Biostatistics Director

Job Summary

Exelixis is hiring a Biostatistics Director to join its expanding oncology drug development team at its Alameda, CA and King of Prussia, PA locations. This leadership role offers an exciting opportunity to develop and execute biostatistical strategies for all phases of clinical trials, ensuring regulatory compliance and scientific rigor. The position is essential for advancing oncology therapies and represents a critical link between statistical analysis and clinical success.


Key Responsibilities

  • Develop and implement department standards, practices, and policies.

  • Lead statistical design, conduct, and analysis of Phase I–IV clinical trials.

  • Author and review statistical analysis plans, study protocols, and case report forms.

  • Perform analysis and interpret clinical trial results to produce reports and publications.

  • Oversee the development of integrated safety and efficacy summaries.

  • Engage with FDA and EU authorities to ensure regulatory alignment.

  • Evaluate and manage CROs, including timelines, deliverables, and budgets.

  • Provide strategic statistical guidance to internal teams and stakeholders.

  • Lead statistical oversight within the assigned therapeutic area, especially oncology.


Required Skills & Qualifications

  • PhD in Statistics/Biostatistics with 8+ years experience, or MS with 11+ years, or BS with 13+ years of relevant experience.

  • Minimum 15 years of experience preferred in pharma/biotech, especially oncology trials.

  • In-depth knowledge of CDISC standards, SDTM/ADaM specifications.

  • Expertise in statistical software: SAS, EAST, nQuery, Cytel Studio.

  • Strong understanding of FDA/EU statistical guidelines and regulatory processes.

  • Proven ability in project management, vendor negotiations, and budget oversight.

  • Excellent problem-solving, communication, and leadership skills.


Perks & Benefits

  • Competitive salary: $187,500 – $266,000 annually.

  • Comprehensive health, dental, and vision insurance.

  • 401(k) with generous company contributions.

  • Discretionary annual bonus eligibility.

  • Employee stock purchase and long-term incentive plans.

  • 15 vacation days, 17 paid holidays, 10 sick days annually.

  • Company-wide winter shutdown in December.

  • Flexible spending accounts, disability, and life insurance.


Company Description

Exelixis is a leading biotech company dedicated to the discovery and development of cancer therapies. With a focus on precision oncology, Exelixis leverages cutting-edge science to address unmet medical needs and improve patient outcomes worldwide.


Work Mode

On-site (Alameda, CA or King of Prussia, PA)


Call to Action

Ready to lead cutting-edge oncology trials? Apply now to become Biostatistics Director at Exelixis and help transform cancer treatment globally.