Talent.com
Lead Statistical Programmer
Lead Statistical ProgrammerKatalyst HealthCares & Life Sciences • San Francisco, CA
Lead Statistical Programmer

Lead Statistical Programmer

Katalyst HealthCares & Life Sciences • San Francisco, CA
[job_card.variable_days_ago]
[job_preview.job_type]
  • [job_card.full_time]
[job_card.job_description]

Job Description :

The Contract Lead Programmer serves as a senior, hands-on programmer responsible for managing statistical programming activities across multiple clinical trials and therapeutic areas. The role oversees external CRO partners to ensure high-quality, timely, and compliant delivery of analysis datasets, tables, listings, and figures that support clinical development and regulatory submissions. The position involves hands-on technical leadership and requires comprehensive and detailed knowledge of statistical programming languages and software, filing support, clinical trial databases, and the drug development process.

Responsibilities :

  • Lead statistical programming activities and deliverables (, SDTM / ADaM datasets, tables, listings, figures, review esub data packages with Pinnacle ) across multiple studies and programs, serving as the primary programming point of contact. Must be able to review TMF for programming deliverables, including SAP.
  • Oversee CRO programming activities by reviewing programming plans, SDTM / ADaM specifications, TLF shells, validation strategies, and issue logs.
  • Monitor internal and CRO delivery against timelines, quality metrics, and contractual obligations; identify risks and implement mitigation or corrective actions as needed.
  • Ensure consistency of standards, templates, macros, and processes across internal and external teams, and drive adoption of programming best practices.
  • Provide hands-on programming support to complex or high-priority analyses, ad-hoc requests, and regulatory responses, as needed.
  • Partner with biostatistics to design, implement, and maintain programming development plans for each project, ensuring timely and high-quality deliverables aligned with internal and industry standards.
  • Partner with data management to apply CDISC standards during CRF design and database development.
  • Partner with biostatistics, data management, clinical, regulatory, pharmacovigilance, and project management to align programming strategies with study-level plans and regulatory expectations.
  • Collaborate with medical writing, clinical, and regulatory on study-level initiatives.
  • Support inspection and audit readiness by ensuring appropriate documentation, traceability, and reproducibility of programming deliverables from both internal and CRO teams.

Minimum Education, Certifications, Licenses, and Experience :

  • Master's degree (or equivalent experience) in statistics, computer science, mathematics, or a related field.
  • years of programming experience in the pharmaceutical, biotechnology, or CRO industry.
  • years of experience as a lead programmer in statistical programming and CRO oversight.
  • Proven record in developing and implementing statistical programming standards and procedures.
  • In-depth knowledge of CDISC (CDASH, SDTM, ADaM) standards and regulatory submission requirements.
  • Advance proficiency in Base SAS, SAS / STAT, SAS Macro language, and SAS SQL; SAS / GRAPH a plus (SAS version or higher).
  • Proficient in coding, debugging, and optimizing new and existing programs.
  • Experience leading studies and supporting NDA and EMEA submissions.
  • Adaptable, detail-oriented, effective under pressure with initiative to take on new challenges.
  • Demonstrated ability to establish and articulate a plan for a team to ensure appropriate focus and direction.
  • Excellent analytical, problem-solving, organizational, and multitasking abilities.
  • Excellent communication and interpersonal skills, both verbal and written.
  • Collaborative team player with a customer-focused mindset; strives to support others to succeed.
  • Ability to communicate technical information to non-scientists, and willingness to educate the internal team.
  • Committed to quality and maintaining a positive attitude under shifting priorities.
  • Ability to contribute to strategic planning for data standards, system infrastructure, and process optimization initiatives.
    • [job_alerts.create_a_job]

    Statistical Programmer • San Francisco, CA

    [internal_linking.similar_jobs]
    Senior Manager, REMS Data Programmer

    Senior Manager, REMS Data Programmer

    Jazz Pharmaceuticals • Redwood City, California, USA
    [job_card.full_time]
    If you are a current Jazz employee please apply via the Internal Career site.Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and ...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Senior Director, Data and AI Architecture Leader

    Senior Director, Data and AI Architecture Leader

    Dynavax Technologies • Emeryville, CA, United States
    [job_card.full_time]
    This position can be 100% remote, but must be located in the United States.Dynavax is a commercial-stage biopharmaceutical company developing and commercializing novel vaccines to help protect the ...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Lecturer - Department of Statistics - College of Computing, Data Science and Society

    Lecturer - Department of Statistics - College of Computing, Data Science and Society

    InsideHigherEd • Berkeley, California, United States
    [job_card.full_time]
    Lecturer - Department of Statistics - College of Computing, Data Science and Society.The UC academic salary scales set the minimum pay at appointment. See the following table(s) for the current sala...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Staff Systems Engineer

    Staff Systems Engineer

    Bio-Rad Laboratories • Hercules, CA, United States
    [job_card.full_time]
    Working within Bio-Rad's Life Science R&D Group as a Systems Engineer, you will take engineering concepts, requirements and transform them into functional prototypes and finished products that impr...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Research Engineer, Codex

    Research Engineer, Codex

    OpenAI • San Francisco, CA, United States
    [job_card.full_time]
    The Codex team is responsible for building state-of-the-art AI systems that can write code, reason about software, and act as intelligent agents for developers and non-developers alike.Our mission ...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Lead Statistical Programmer

    Lead Statistical Programmer

    VirtualVocations • Oakland, California, United States
    [job_card.full_time]
    A company is looking for a Lead Statistical Programmer.Key Responsibilities Lead statistical programming activities and deliverables across multiple studies, serving as the primary programming po...[show_more]
    [last_updated.last_updated_1_day] • [promoted]
    Director, Statistical Programming Standards & Infrastructure

    Director, Statistical Programming Standards & Infrastructure

    Exelixis • Alameda, CA, United States
    [job_card.full_time]
    The Director of Statistical Programming Standards & Infrastructure provides strategic leadership and oversight for the development, implementation, and maintenance of global statistical programming...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Pathology opportunity at our Regional Laboratory Berkeley

    Pathology opportunity at our Regional Laboratory Berkeley

    Kaiser Permanente - The Permanente Medical Group, Inc. -Northern California • Berkeley, US
    [job_card.full_time]
    Reduced schedules (with pro-rated compensation) may be available.Some incentive opportunities are estimates based on potential premium pay. The Permanente Medical Group, Inc.American Medical Special...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Lead Research Engineer - Codes and Standards

    Lead Research Engineer - Codes and Standards

    TRC Companies • Oakland, CA, United States
    [job_card.full_time] +1
    TRC has long set the bar for clients who require more than just engineering, combining science with the latest technology to devise innovative solutions that stand the test of time.From pipelines t...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Beyond Moore Computational Research Scientist

    Beyond Moore Computational Research Scientist

    Lawrence Berkeley National Laboratory • Berkeley, CA, United States
    [job_card.full_time]
    Applied math and Computational Sciences Division.Beyond Moore Computational Research Scientist to evaluate and develop devices to hardware / circuit co-design flow for architectural specializations f...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Director, Data and AI Alliances

    Director, Data and AI Alliances

    Anaplan • San Francisco, CA, United States
    [job_card.full_time]
    At Anaplan, we are a team of innovators focused on optimizing business decision-making through our leading AI-infused scenario planning and analysis platform so our customers can outpace their comp...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Pathology opportunity at our Regional Laboratory Berkeley

    Pathology opportunity at our Regional Laboratory Berkeley

    HealthEcareers - Client • Berkeley, CA, USA
    [job_card.full_time]
    Reduced schedules (with pro-rated compensation) may be available.Some incentive opportunities are estimates based on potential premium pay. The Permanente Medical Group, Inc.American Medical Special...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Assistant, Associate, Full Professor of Clinical Optometry

    Assistant, Associate, Full Professor of Clinical Optometry

    UC Berkeley School of Optometry • Berkeley, California, United States
    [job_card.full_time]
    Assistant, Associate, Full Professor of Clinical Optometry - Low Vision / Vision Rehabilitation / Geriatric Vision - School of Optometry POSITION OVERVIEW Salary range : The current salary range for thi...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Lecturer - Department of Statistics - College of Computing, Data Science and Society

    Lecturer - Department of Statistics - College of Computing, Data Science and Society

    University of California-Berkeley • Berkeley, CA, United States
    [job_card.full_time]
    The UC academic salary scales set the minimum pay at appointment.See the following table(s) for the current salary scale(s) for the Lecturer position : https : / / www. The current full-time salary range...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Senior Research Engineer - Datasets

    Senior Research Engineer - Datasets

    Canva • San Francisco, CA, United States
    [job_card.full_time]
    Join the team redefining how the world experiences design.Hey, hello, g'day, mabuhay, kia ora, 你好, hallo, vítejte!.We know job hunting can be a little time consuming and you're probably keen to fin...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Director, Statistical Programming

    Director, Statistical Programming

    Corcept Therapeutics • Redwood City, CA, United States
    [job_card.full_time]
    Director, Statistical Programming.Corcept is leading the way in the research and development of cortisol modulators, molecules that regulate cortisol activity at the glucocorticoid receptor (GR).To...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Lead Research Engineer in AI and Code Technology

    Lead Research Engineer in AI and Code Technology

    Harrison Clarke • Alameda, CA, United States
    [job_card.full_time]
    A rapidly evolving and highly technical AI company is seeking a.This is your chance to be at the cutting edge of AI, contributing to the design and evaluation of models that comprehend, generate, a...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Associate - PhD

    Associate - PhD

    Cornerstone Research • Menlo Park, CA, United States
    [job_card.full_time]
    US-CA-San Francisco and Silicon Valley | US-MA-Boston | BE-Brussels | US-IL-Chicago | UK-London | US-CA-Los Angeles | US-NY-New York | US-DC-Washington. Cornerstone Research provides economic and fi...[show_more]
    [last_updated.last_updated_30] • [promoted]