As the Principal Statistical Programmer reporting to the Senior Director of Statistical Programming, you will be accountable for all statistical programming deliverables in adherence to company SOPs and ICH/GCP. You will also help to create and implement Statistical Programming policies and procedures.

This role is based out of our San Francisco, CA office.

Your work will primarily encompass:

• Effectively manage and oversee statistical programming resources including contractors and CROs related to statistical programming deliverables to ensure high-quality within timeline and budget
• 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
• 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
• Conduct hands-on programming of deliverables including but not limited to IDMC meetings, DSUR, IB safety data review, Board meetings, Exploratory Analysis, etc.
• Ensure timely delivery of all statistical deliverables for each study assigned
• Collaborate with study statistician and study team members to come up with 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

Knowledge:

• 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
• Strong SAS programming and graphic programming skills
• Able to guide the successful completion of major programs and projects
• Strong analytical and communication skills
• Knowledge and experience in meeting regulatory guidelines, including both FDA and international regulatory agencies
• Broad knowledge of medical/biological terminology in relevant therapeutic areas

Experience:

• 12 years of related experience with a Bachelor’s degree in Statistics; or 8 years and a Master’s degree; or a PhD with 5 years experience
• Experience of leading 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
• 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
• Experience in management of CROs with respect to statistical programming
• Building and maintaining strong collaboration with key stakeholders from different disciplines across the organization

Attributes:

• Leadership skills in proactively prioritizing tasks, flexible to changes, conflict resolution, and effective partnership
• Strong verbal and written communication skills
• Effectively represent statistical programming in multidisciplinary meetings
• 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
• Have impeccable professional ethics, integrity and judgement

COMP RANGE TEXT:

The base pay range for this position is expected to be $189,000 to $201,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits.

#LI-MK1