Exelixis · 2 months ago
Associate Statistical Programming Director
Alameda HQ
Full-time
Onsite
Director/Executive
$162K/yr - $230K/yr
9+ years expExelixis Inc is a company focused on innovation in the biotech industry, and they are seeking an Associate Statistical Programming Director to lead statistical programming activities at the study or project level. The role involves utilizing statistical software to create and maintain various programming outputs, ensuring quality control, and collaborating with clinical data management and biostatistics teams.
BiotechnologyHealth CarePharmaceutical
Responsibilities
Serve as macro librarian responsible for maintaining existing macros, providing training on macro usage, developing documentation and training materials, being point of contact for macro questions, facilitating meetings to discuss enhancements to existing macros with stakeholders and identifying requirements for new macros and standard programs
Follow SDLC (Software Development Lifecycle) to create new global macros and standard programs to meet department needs
Independently develop SAS or other programs, and specifications, for use in study or other analyses, such as Integrated Safety Summaries
As the lead or support programmer on studies, work with clinical data management staff and biostatisticians to coordinate and schedule data transfers and the delivery of required outputs
As the lead programmer, responsible for helping to identify when additional programming resources are needed for a project, communicating with their supervisor to arrange for those resources, and coordinating and overseeing other statistical programmers’ work on the project as needed
Oversee the development of datasets in ODS, SDTM, & ADaM format by CROs, including clear documentation of the process that was followed in the form of specifications, trackers, and checklists
Responsible for programming QC oversight of CRO deliverables such as analysis datasets and tables, listings, and figures (TLFs)
Must be able to program defensively, check results, and consistently produce accurate output
Adhere to FDA regulations regarding training records, guidelines, and SOPs
Adhere to company SOPs/WIs and department guidelines
Produce study datasets and programs that will help meet CDISC standards
Support ad-hoc requests as needed
Work on multiple tasks at the same time and prioritize tasks to meet business needs
Trouble-shoot technical and project issues
Help with the infrastructure development of the department
Assist team to ensure timelines for the study and/or project are met
Assist with training new employees and contractors, in particular on macros, study specifics and departmental programming conventions and standards
Communicate with outside departments and/or groups
Meet timelines on a regular basis
Qualification
Required
BS/BA degree in related discipline and a minimum of eleven years of related experience; or
MS/MA degree in related discipline and a minimum of nine years of related experience; or
PhD in related discipline and a minimum of five years of related experience; or
Equivalent combination of education and experience
May require certification in assigned area
At least eight years' experience in Pharmaceutical/Biotech programming
Demonstrated proficiency in SAS/Base, SAS/Stat, and SAS/Macros
Ability to communicate verbally and in writing in a clear and timely manner
Leads or manages 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
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
Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors
Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation of criteria for obtaining results
Uses professional concepts and company's policies and procedures to solve a wide range of difficult problems in imaginative and practical ways
Networks with key contacts outside own area of expertise
Preferred
UNIX, CDISC, and SAS graphics experience desirable
Experience with Oncology clinical trials a plus
NDA submission experience a plus
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
2026-01-07
Investor's Business Daily
2025-12-22
Company data provided by crunchbase