Olema Oncology · 2 weeks ago
Senior Statistical Programmer
San Francisco, CA
Full-time
Onsite
Senior Level
$160K/yr - $180K/yr
6+ years expOlema Oncology is dedicated to developing better medicines for breast cancer and beyond. As the Senior Statistical Programmer, you will be accountable for all assigned statistical programming deliverables in adherence to company SOPs and ICH/GCP, working on late phase trials to help patients with breast cancer.
BiopharmaBiotechnologyHealth CareMedicalOncologyPharmaceutical
Responsibilities
Conduct hands-on validation/QC of CRO deliverables to ensure high-quality (SDTMs, ADaMs, TFLs) and ensure accuracy of clinical trial results for internal and external audiences
Conduct hands-on programming of deliverables including but not limited to IDMC meetings, DSUR, IB safety data review, Board meetings, Exploratory Analysis, Safety Detection, etc
Ensure all relevant deliverables including investigator brochures, publications, all regulatory submissions (SDTM/ADaM compliance), supporting documentation (define.xml, reviewer’s guide, annotated CRFs) conforms to SOPs and to regulatory specifications
Ensure timely delivery of all statistical deliverables for each study assigned
Collaborate with study team members to negotiate timelines for statistical programming deliverables and other related action items
Follow departmental SOPs and processes for operational excellence
Lead statistical programming activities for regulatory submissions following CDISC standards
Review key study-related documents including but not limited to SAP, CRFs, DTS/DTA and data management plan
Take ownership for the completion of SDTM and ADAM specifications for assigned studies
Qualification
Required
Bachelor's degree is required
Thorough understanding of clinical trial reporting process, as well as regulatory reporting requirements including electronic data submissions and CDISC implementation
Thorough knowledge of SDTM/ADaM specifications and programming
Knowledge and experience in meeting regulatory guidelines, including both FDA and international regulatory agencies
Broad knowledge of medical/biological terminology in relevant therapeutic areas
Strong SAS programming and graphic programming skills
Minimum of 8 years of related experience with a Bachelor's degree; or 6 years and a Master's degree; or a PhD with 3 years experience
Experience of working both early and late-phase clinical studies including programming and validation of SDTM and ADaM data sets, tables, figures, and listings
Strong level SAS programmer with experience in delivering complex programming assignments, macros and analyses
Strong ability to produce in-house ADaM datasets and TFLs for CSR and for other key deliverables is a must
Able to guide the successful completion of major programs and projects
Strong analytical skills
Building and maintaining strong collaboration with key stakeholders from different disciplines across the organization
Skills in proactively prioritizing tasks, flexible to changes, conflict resolution, and effective partnership
Strong verbal and written communication skills
Commitment to excellence
Self-motivated and enthusiastic, fast learner who can identify the core project challenges and expeditiously change course as required in a fast-paced organization
Impeccable professional ethics, integrity and judgement
Preferred
advanced degree (MS, PharmD, PhD)
Experience with oncology trials
Experience with R
Experience with SAS Graphics
Experience with BLA or NDA/sNDA to FDA/EMA
Experience with other major global health authority submission
Benefits
Equity
Bonus
Benefits
Competitive compensation and benefits package
Company
Olema Oncology
Olema Oncology is a preclinical biotechnology company that develops new drugs for the treatment and prevention of breast cancer.
51-200 employees
H1B Sponsorship
Olema Oncology 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 (4)
2024 (3)
2022 (2)
Funding
Current Stage
Public CompanyTotal Funding
$765.05MKey Investors
Paradigm BioCapital AdvisorsSilicon Valley BankVivo Capital
2025-11-20Post Ipo Equity· $190M
2024-12-02Post Ipo Equity· $250M
2023-09-05Post Ipo Equity· $130M
Leadership Team
Naseem Zojwalla
Chief Medical Officer
Shane Kovacs
Chief Operating and Financial Officer
Recent News
2025-12-25
thefly.com
2025-12-11
Company data provided by crunchbase