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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
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  • [job_card.full_time]
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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.
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