Director of Statistical Programming

3 days ago

South San Francisco, California, United States Meet Full time
{"title": "Director of Statistical Programming", "content": "Job Summary

The Director of Statistical Programming will provide strategic oversight, planning, and execution of the statistical programming function to support an expanding portfolio of clinical development programs. This role will collaborate with key stakeholders across Biometrics, Data Management, Biostatistics, and Data Science to build a top-tier biometrics function.

The Director will ensure high-quality, timely, and accurate delivery of statistical programming outputs and will oversee both internal and external programming resources. In addition, this leader will provide scientific leadership, working cross-functionally to ensure data deliverables meet the highest standards for regulatory submission.

This position reports to the Vice President of Biometrics and will lead the statistical programming function, contributing to delivery excellence, and providing technical, strategic, and operational direction.

Key Responsibilities
  1. Provide strategic leadership to the statistical programming function, aligning with organizational goals and clinical program objectives.
  2. Lead and manage the statistical programming team, fostering a culture of collaboration, innovation, and excellence.
  3. Provide strategic input into the setup of clinical data repositories and ensure compliance with 21 CFR Part 11 standards for SAS computing environments.
  4. Collaborate with cross-functional teams (Medical, Biostatistics, Data Management, Medical Writing, Safety) to develop and implement standardized analysis datasets, Tables, Listings, and Figures (TLFs), and a global standard eCRF library for multiple therapeutic areas.
  5. Develop, test, validate, and execute standard macros and utilities to support statistical programming activities.
  6. Review clinical trial documentation such as clinical protocols, data management plans, CRFs, SAP, and CSRs.
  7. Act as the primary point of contact for all statistical programming activities outsourced to CROs, ensuring timely and quality deliverables.
  8. Lead the development and optimization of biometric processes, ensuring efficiency, quality, and compliance with industry best practices.
  9. Provide technical leadership and project management for multiple studies, overseeing statistical programming deliverables.
  10. Support programming for clinical study reports (CSR), integrated summaries of safety (ISS), efficacy (ISE), DSUR, and other regulatory submissions.
  11. Generate/review CDISC SDTM and ADaM datasets, SAS export files, and for electronic submission.
  12. Collaborate with key internal stakeholders to define programming-related study deliverables.
  13. Perform additional duties as assigned.
Qualifications
  1. Bachelor's or Master's degree in Statistics, Mathematics, or a related field, with 10+ years of experience in pharmaceutical or biotech statistical programming.
  2. Expertise in CDISC submission requirements (SDTM, ADaM,, validation rules).
  3. Advanced experience in writing CDISC standard dataset specifications and generating SDTM/ADaM datasets.
  4. Strong proficiency in SAS programming (SAS Base, SAS/Macro, SAS/Graph, SAS/Stat).
  5. Experience managing CROs and/or centralized statistical programming teams.
  6. Solid understanding of the drug development process, especially in a biotech setting.
  7. Excellent communication and collaboration skills to effectively work across multidisciplinary teams.
"}

  • Director of Statistical Programming

    3 weeks ago

    San Francisco, California, United States Barrington James Full time

    Director of Statistical Programming - Biotech IndustryWe are partnering with a rare disease focused Biotech company to seek a Director of Statistical Programming.The company is focused on a rare disease with significant unmet medical needs, offering a unique opportunity to make a meaningful impact.The team is experienced and collaborative, with two...

  • Statistical Programming Lead

    2 weeks ago

    San Francisco, California, United States Barrington James Full time

    Biotech Statistical Programming OpportunityWe are partnering with a rare disease focused Biotech in San Francisco to find a skilled Statistical Programming professional.The company is focused on a rare disease with unmet medical needs, offering a chance to make a meaningful impact.The team is experienced, with two Director-level programmers, and you will...

  • Director of Safety Statistics

    4 hours ago

    South San Francisco, California, United States AbbVie Full time

    Job DescriptionThe Director of Safety Statistics plays a critical role in providing scientific and strategic input for assigned clinical development projects. This position requires collaboration with patient safety, clinical, and regulatory experts to advance medicines to patients.Key ResponsibilitiesLead the statistical support for one or more clinical...

  • Manager of Statistical Programming

    4 weeks ago

    San Francisco, California, United States Elan Solutions LLC Full time

    Job OverviewPosition: Manager of Statistical Programming (Full Time, Remote)Company: Elan Solutions LLCSalary Range: $150,000 - $153,800Essential Qualifications:Minimum 5 years of experience in a Contract Research Organization (CRO)At least 3 years of experience as a Study Lead3+ years in Personnel ManagementAbility to work within Pacific Time ZoneExperience...

  • Senior Statistical Programming Lead

    4 weeks ago

    San Diego, California, United States RBW Consulting Full time

    Position: Associate Director of Statistical ProgrammingLocation: San Diego, CA (On-Site)Type: Full-timeKey Responsibilities:Direct statistical programming initiatives, ensuring exceptional quality in clinical program deliverables.Manage relationships with external vendors regarding statistical programming outputs (SDTM, ADaM, TFLs).Offer technical guidance...

  • Senior Manager, Statistical Programming Lead

    3 weeks ago

    San Francisco, California, United States Meet Recruitment Limited Full time

    Job Title: Senior Manager, Statistical ProgrammingJob Summary:Meet Recruitment Limited is seeking an experienced Senior Manager of Statistical Programming to join our team. As a key member of our clinical stage biopharma client, you will be responsible for hands-on programming for clinical studies, including exploratory analyses, regulatory responses, and...

  • Director of Biostatistics and Programming

    2 weeks ago

    San Francisco, California, United States BioTalent Canada Full time

    About the RoleWe are seeking a highly skilled and experienced Director of Biostatistics and Programming to join our Clinical Development team at Zymeworks. As a key member of our leadership team, you will be responsible for developing and implementing strategic plans to drive the growth and success of our biometrics and statistical programming...

  • Statistical Programming Lead

    2 weeks ago

    San Diego, California, United States Arrowhead Pharmaceuticals Full time

    About the RoleArrowhead Pharmaceuticals is seeking a highly skilled Statistical Programming Lead to join our rapidly growing biometrics team. As an internal expert in statistical programming, you will provide technical leadership and statistical programming input to collaborate with other functional teams at Arrowhead, including Clinical Development and...

  • Statistical Programmer

    5 days ago

    San Francisco, California, United States Katalyst Healthcares & Life Sciences Full time

    Job Title: Statistical ProgrammerKatalyst Healthcares & Life Sciences is seeking a highly skilled Statistical Programmer to join our team.Responsibilities:Lead the Development of Statistical Programs: Develop, validate, and maintain statistical programs using SAS to generate tables, listings, and figures (TLFs) for clinical trial data analysis.SDTM Domain...

  • Statistics Instructor for Statway Program

    4 weeks ago

    San Jose, California, United States San Jose State University Full time

    Department Overview UNVS 15 is a statistics course designed for students requiring additional assistance. This course is based on the Statway College + Corequisite framework, which is part of the Carnegie Math Pathways curriculum provided by WestEd. Position SummaryWe are seeking applications for part-time instructors to deliver UNVS 15, Statway:...

  • Statistical Programmer

    2 weeks ago

    San Francisco, California, United States Katalyst Healthcares & Life Sciences Full time

    {"title": "Statistical Programmer", "content": "Job SummaryKatalyst Healthcares & Life Sciences is seeking a skilled Statistical Programmer to lead the development, validation, and maintenance of statistical programs using SAS. The ideal candidate will have a strong background in clinical programming, CDISC standards, and regulatory submission...

  • Executive Director of Biostatistics

    3 days ago

    South San Francisco, California, United States Meet Full time

    Executive Director Biostatistics Job DescriptionJob Summary:The Executive Director of Biostatistics will provide strategic leadership and oversight of the biostatistics function to support clinical development programs. This role offers strategic statistical input for drug development planning, including feasibility assessments, study design, statistical...

  • Senior Vice President, Statistical Sciences

    3 weeks ago

    South San Francisco, California, United States Annexon Bioscience Full time

    Work Location Corporate Headquarters - Hybrid Position Overview We are in search of a proactive and seasoned Senior Vice President of Statistical Sciences to spearhead our Statistical Sciences division. The ideal candidate will deliver strategic leadership and operational management for all facets of biostatistics, statistical programming, modeling,...

  • Principal Statistical Programmer

    2 days ago

    San Francisco, California, United States IQVIA Full time

    Job Title: Principal Statistical ProgrammerLocation: Home-based in the USAbout the RoleWe are seeking a highly skilled Principal Statistical Programmer to join our team at IQVIA. As a key member of our Statistical Programming department, you will be responsible for planning, coordinating, and implementing complex statistical programming solutions for our...

  • Lead Statistical Analyst

    4 hours ago

    San Francisco, California, United States Unreal Gigs Full time

    Job Title: Lead Statistical AnalystUnreal Gigs is seeking a highly skilled Lead Statistical Analyst to join our team. As a key member of our data analytics team, you will be responsible for leading statistical analysis initiatives and driving the development of advanced analytical solutions.Job DescriptionCompany Overview: At Unreal Gigs, we harness the...

  • Associate Director, Biostatistics

    1 day ago

    South San Francisco, California, United States BioSpace, Inc. Full time

    Job SummaryWe are seeking an experienced Associate Director, Statistics to join our team at BioSpace, Inc. This role will provide statistical support across a broad range of nonclinical areas with a focus on Chemistry, Manufacture and Control (CMC), expanding and broadening the application of Biostatistics.Key ResponsibilitiesApply statistical techniques to...

  • Program Director

    3 days ago

    San Francisco, California, United States Oakland Venue Management, Inc. Full time

    Job Title: Program DirectorCompany Description:Oakland Venue Management, Inc. is a leading provider of venue management services, dedicated to delivering exceptional experiences for our clients and their guests. With a strong focus on customer satisfaction, we strive to create vibrant and inclusive communities through our work.Job Summary:The Program...

  • Associate Director, Biostatistics

    2 days ago

    South San Francisco, California, United States BioSpace, Inc. Full time

    Job SummaryWe are seeking an experienced Associate Director to join our team in CMC Statistics. The successful candidate will provide statistical support across a broad range of nonclinical areas, with a focus on Chemistry, Manufacture and Control (CMC). This role will involve expanding and broadening the application of Biostatistics, as well as helping the...

  • Statistical Research Consultant

    4 weeks ago

    San Jose, California, United States Cook County Sheriff's Office Full time

    Position OverviewThe Cook County Sheriff's Office (CCSO) is looking for a dedicated full-time Data Insights Analyst. This role will support the Director of Research in delivering precise, timely, and data-informed evaluations of various operations within the CCSO, including the management of individuals in custody, staffing dynamics, law enforcement...

  • Shelter Director

    2 weeks ago

    San Francisco, California, United States Salvation Army Full time

    Job SummaryThe Salvation Army is seeking a highly skilled and experienced Shelter Director to oversee the operations of the Harbor House Family Emergency Shelter. As a key member of our team, you will be responsible for managing the day-to-day activities of the shelter, ensuring the well-being and safety of our clients, and providing exceptional leadership...