Exelixis · 1 week ago
Director, Statistical Programming Standards & Infrastructure
Alameda, CA
Full-time
Onsite
Director/Executive
$198K/yr - $282K/yr
8+ years expExelixis is a biotechnology company focused on developing innovative cancer therapies. The Director of Statistical Programming Standards & Infrastructure provides strategic leadership for the development and implementation of global statistical programming standards, ensuring compliance with regulatory requirements and driving innovation across studies and submissions.
BiotechnologyHealth CarePharmaceutical
Responsibilities
Define and execute the vision for statistical programming standards and infrastructure aligned with organizational goals
Establish governance for global programming standards, tools, and processes
Oversee creation, validation, and lifecycle management of global macros, standard programs, and reusable code libraries
Ensure adherence to SDLC principles for all programming tools and infrastructure components
Drive initiatives to enhance automation, scalability, and efficiency in programming workflows
Collaborate with IT to maintain robust, secure, and compliant programming environments
Ensure deliverables meet CDISC standards (SDTM, ADaM) and regulatory requirements (e.g., FDA, EMA)
Oversee quality control processes for CRO deliverables and internal outputs, including datasets and TLFs
Partner with Biostatistics, Clinical Data Management, and other stakeholders to align standards and infrastructure with clinical development needs
Serve as subject matter expert for programming standards during audits and regulatory inspections
Lead and mentor a team of statistical programmers and standards specialists
Manage resource allocation, training and career development for team members
Identify emerging technologies and best practices to advance programming capabilities
Champion process improvements and standardization initiatives across the organization
Directly manage a team of statistical programming standards and/or infrastructure
Provide leadership, coaching and performance management to ensure team success
Qualification
Required
BS/BA degree in a related discipline and a minimum of 13 years of relevant experience; or
MS/MA degree in a related discipline and a minimum of 11 years of relevant experience; or
PhD in a related discipline and a minimum of 8 years of relevant experience; or
Equivalent combination of education and experience
Extensive experience in pharmaceutical/biotech statistical programming, including NDA/BLA submissions
Proven track record in developing and implementing programming standards and infrastructure
Strong proficiency in SAS/Base, SAS/Stat, SAS/Macro; programming experience in R and Python is a plus; experience with CDISC standards and SDLC
Strategic thinking with ability to translate vision into actionable plans
Strong leadership and team management skills
Good managerial and organizational skills
Excellent communication and collaboration abilities
Knowledge of appropriate FDA regulations, industry standards and guidance documents
Understands clinical research process, trial designs, and the development of protocols and analysis plans
Experience authoring SOPs and work instructions
Works on highly complex problems requiring strategic analysis and innovative solutions
Influences organizational policies and practices related to statistical programming standards and infrastructure
Networks extensively with internal and external stakeholders to drive alignment and adoption of standards
Preferred
Familiarity with oncology clinical trials
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
GlobeNewswire
2026-01-23
2026-01-18
2026-01-12
Company data provided by crunchbase