Exelixis · 1 hour ago
Associate Biostatistics Director (Biotech, Oncology)
Alameda, CA
Full-time
Onsite
Lead/Staff, Director/Executive
$166K/yr - $236K/yr
5+ years expExelixis is a biotech company focused on oncology, and they are seeking an Associate Biostatistics Director to provide expertise in statistical issues and clinical trial design. The role involves collaborating with various teams to plan, conduct, and analyze clinical trials while managing deliverables and adhering to regulatory guidelines.
BiotechnologyHealth CarePharmaceutical
Responsibilities
Work with project team members on developing clinical protocol. Review CRFs, CRF edit checks and CRF completion guidelines. Author statistical analysis plan, TLF shells and Table of contents for outputs to be generated. Review ADaM specifications and verify primary and secondary efficacy endpoints
Perform analysis, interpret study results, and collaborate with clinical team to produce interim reports, final reports, and publications
Effectively manage CRO to ensure high-quality deliverables within timeline and budget
Oversee programming of ADaMs and TLFs for the study
Responsible for one or more studies with concurrent tasks and timelines
Participate in the validation/QC of key study endpoint analysis and submission deliverables
Apply appropriate regulatory guidelines to the projects
Qualification
Required
MS/MA degree in related discipline and a minimum of 9 years of related experience; or
PhD in related discipline and a minimum of 5 years of related experience; or
Equivalent combination of education and experience
May require certification in assigned area
Knowledge of appropriate regulations, industry standards and guidance documents
Ability to interact effectively with biostatistical, data management, operations, and clinical personnel from CROs and companies collaborating with Exelixis
Developed/reviewed SDTM/ADaM specifications
Strong SAS programming knowledge
Guides the successful completion of major programs, projects and/or functions
Leads or manage the work of others by providing guidance to subordinates or teams based on organizational goals and company policy, with responsibility for results, including costs, methods, and staffing
Uses broad expertise or unique knowledge and skills to contribute to development of company objectives and principles and to achieve goals in creative and effective ways
Develops technical and/or business solutions to complex problems
Identifies and implements methods, techniques, procedures, and evaluation criteria to achieve results
Performs a variety of complicated tasks with a wide degree of creativity and latitude
Has complete understanding and wide application of technical principles, theories, concepts, and techniques
Has good general knowledge of other related disciplines
Applies strong analytical and business communication skills
Preferred
Experience in oncology and study Phases I-III highly preferred
Experience in Biotech/Pharmaceutical industry preferred
Experience with managing CROs in the conduct of clinical trials
Experience with statistical applications and clinical data management procedures in the conduct of clinical trials
Ability to effectively represent Biostatistics and Clinical Data Management in multidisciplinary meetings
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