Exelixis · 5 hours ago
Biostatistics Director
Alameda, CA
Full-time
Onsite
Director/Executive
$188K/yr - $266K/yr
8+ years expExelixis is a biotechnology company focused on developing innovative medicines for cancer. The Biostatistics Director will lead the biostatistics function, overseeing statistical strategy and analyses for clinical trials, ensuring compliance with regulatory requirements, and managing timelines and budgets for contract research organizations.
BiotechnologyHealth CarePharmaceutical
Responsibilities
Work with department head to develop and implement department standards and practices
Direct the statistical design, conduct, and analysis of clinical trials in all phases
Review protocols and case report forms for soundness of trial design
Review and or author statistical analysis plans for all phases of a trial
Perform analysis, interpret study results, and collaborate with clinical team to produce interim reports, final reports, and publications
Direct the development, validation and summary of integrated safety and efficacy summaries
Interact with FDA or EU Authority staff to ensure clinical studies meet regulatory requirements
Attend meetings with FDA or EU Authority to ensure ongoing agreement on project development
Contribute to the development of Requests-for-Proposals
Evaluate and manage contract research organizations and other vendors, including scope-of-work, timelines, deliverables and budgets
Responsible for all statistical oversight within a therapeutic area
Qualification
Required
BS/BA degree in Statistics/Biostatistics or related discipline and a minimum of thirteen years of related experience; or
MS/MA degree in Statistics/Biostatistics or related discipline and a minimum of eleven years of related experience; or
PhD in Statistics/Biostatistics or related discipline and a minimum of eight years of related experience, or
Equivalent combination of education and experience
May require certification in assigned area
In-depth knowledge of CDISC standards
Typically requires a minimum of 15 years of related experience and/or combination of experience and education/training
Comprehensive and detailed knowledge of: statistical experimental designs, analyses and clinical trial requirements, particularly pertaining to oncology trials
Developed/reviewed SDTM/ADaM specifications
Excellent knowledge of FDA/EU statistical guidelines
Management and statistical analysis of data obtained from Phase I – IV studies in support of NDAs
Must have experience in state-of-the-art data organization and statistical analyses using statistical software such as: SAS, EAST, nQuery, Cytel Studio
Guides the successful completion of major programs, projects and/or functions by identifying and implementing appropriate techniques and evaluation criteria
Has understanding of other disciplines such as data management, clinical operation, clinical science, regulatory affairs and drug safety
Project management and contract negotiation with outside vendors
Uses broad expertise or unique knowledge and skills to contribute to development of company objectives and principles and to achieve these goals in creative and effective ways
Develops technical and/or business solutions to complex problems
Interprets, executes and recommends modifications to companywide policies and/or divisional programs. May establish organizational policies in a major segment of the company
Applies strong analytical and business communication skills
Preferred
Managed and or supported clinical trials, preferably in the therapeutic area of oncology and in the biotech/pharmaceutical industry
Preferably led a phase III clinical trial
Direct experience with FDA/EU Authority preferred
Benefits
401k plan with generous company contributions
Group medical, dental and vision coverage
Life and disability insurance
Flexible spending accounts
Discretionary annual bonus program
Sales-based incentive plan
Opportunity to purchase company stock
Receive long-term incentives
15 accrued vacation days in their first year
17 paid holidays including a company-wide winter shutdown in December
Up to 10 sick days throughout the calendar year
Company
Exelixis
Exelixis works is focused on discovering, developing and commercializing therapies for the treatment of cancer and other serious diseases.
1001-5000 employees
H1B Sponsorship
Exelixis has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (39)
2024 (25)
2023 (25)
2022 (28)
2021 (29)
2020 (15)
Funding
Current Stage
Public CompanyTotal Funding
$514MKey Investors
Deerfield
2015-07-23Post Ipo Equity· $135M
2012-02-16Post Ipo Equity· $65M
2010-06-03Post Ipo Debt· $160M
Leadership Team
Michael Morrissey
President and CEO
Christopher Senner
Executive Vice President and CFO
Recent News
2026-01-12
The Motley Fool
2026-01-09
Company data provided by crunchbase