Senior Statistical Programmer

Olema Oncology • San Francisco, CA

8h • $160,000 - $180,000 • Onsite

About The Position

As the Senior Statistical Programmer reporting to the Principal Statistical Programmer, you will be accountable for all assigned statistical programming deliverables in adherence to company SOPs and ICH/GCP. This is a great opportunity to work on late phase trials and be a part of a team helping patients with breast cancer. This role is based out of our San Francisco office and will require about 10% travel. Your work will primarily encompass:

Requirements

• Bachelor’s degree is required; advanced degree (MS, PharmD, PhD) preferred
• 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

Nice To Haves

• Experience with oncology trials is preferred
• Experience with R is a plus
• Experience with SAS Graphics is a plus
• Experience with BLA or NDA/sNDA to FDA/EMA is preferred.
• Experience with other major global health authority submission is a plus

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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Number of Employees: 101-250 employees