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
30+ days ago
Job type
  • Full-time
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.

Create a job alert for this search

Lead Statistical Programmer • San Francisco, CA

Similar jobs

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

InsideHigherEdBerkeley, California, United States
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

 • Promoted

Pathologist

Kaiser Permanente - The Permanente Medical Group, Inc. -Northern CaliforniaRedwood City, US
Full-time

BE/BC Pathologist to join our team in Redwood City, CA.The Permanente Medical Group, Inc.Northern and Central California and an 80-year tradition of providing quality medical care.Board Certificati...Show more

 • Promoted

Pathologist in Redwood City

The Permanente Medical Group, Inc. - N.CaliforniaRedwood City, CA, US
Full-time

Pathologist Opportunity in Redwood City, CA with Kaiser Permanente.Leading the future of health care.Kaiser Permanente / The Permanente Medical Group.BE/BC Pathologist to join our team in Redwood C...Show more

 • Promoted

Associate Statistical Programming Director

Exelixis, Inc.Alameda, CA, United States
Full-time

Associate Statistical Programming Director page is loaded## Associate Statistical Programming Directorlocations: Alameda, CA: Alameda HQtime type: Full timeposted on: Posted Todayjob requisition id...Show more

 • Promoted

Postdoc - Deep Learning and Pathology - University of California, San Francisco

ImageSan Francisco, CA, United States
Full-time

We’re looking for highly motivated postdoctoral candidates with a background in machine learning, pathology, biomedical image analysis, or related fields.The candidate would define or join a deep l...Show more

 • Promoted

Pathologist

HealthEcareers - ClientRedwood City, CA, USA
Full-time

BE/BC Pathologist to join our team in Redwood City, CA.The Permanente Medical Group, Inc.Northern and Central California and an 80-year tradition of providing quality medical care.Board Certificati...Show more

 • Promoted

Bioinformatics Programmer

LumicitySan Francisco, CA, United States
Full-time

Direct message the job poster from Lumicity.Contract Recruitment Consultant at Lumicity | Medical Affairs, Bio Statistics, Medical Writing, Clinical Operations, Clinical Research, and Clinical….Dur...Show more

 • Promoted

Senior Manager, Statistical Programming (Oncology)

AbbVie, IncSan Francisco, CA, United States
Full-time

Company Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow.We strive to...Show more

 • Promoted

Bioinformatics Programmer

University of California - San FranciscoSan Francisco, California, United States
Full-time

Under direct supervision, Bioinformatics Programmer applies machine learning and artificial intelligence (AI) concepts for the analysis of large scale genomics, single cell, and other biological da...Show more

 • Promoted

Bioinformatics Core Director - Lead Genomics & Data Science

Gladstone InstitutesSan Francisco, CA, United States
Full-time

A leading biomedical research organization located in San Francisco is seeking a Director for their Bioinformatics Core.This role involves guiding a team in advancing biomedical research, managing ...Show more

 • Promoted

Lead Statistical Programmer

Katalyst CROSan Francisco, CA, United States
Full-time

Lead Statistical Programmer – Katalyst CRO.The Contract Lead Programmer serves as a senior, hands‑on programmer responsible for managing statistical programming activities across multiple clinical ...Show more

 • Promoted

Travel Mammography Tech - $2,964 per week in Redwood City, CA

AlliedTravelCareersRedwood City, CA, US
Full-time

AlliedTravelCareers is working with Medical Solutions to find a qualified Mammography Tech in Redwood City, California, 94062!.A facility in Redwood City, CA is seeking its next amazing Mammography...Show more

 • Promoted

Senior ML Platform Leader: Inference & APIs

Apple Inc.San Francisco, CA, United States
Full-time

A leading technology company is seeking a Senior Machine Learning Manager in San Francisco to lead a team of engineers developing critical software infrastructure for ML applications.The successful...Show more

 • Promoted

Senior ML Research Leader - Hybrid, Equity & Impact

CognitivSan Mateo, CA, United States
Full-time

A leading AdTech firm in San Mateo is seeking a Technical Leader to oversee machine learning innovation and guide a team of researchers.This hybrid role involves strategic direction, hands-on contr...Show more

 • Promoted

Foundation Model Data ML Engineer & Researcher

Liquid AISan Francisco, CA, United States
Full-time

A leading AI technology firm in California is seeking a highly skilled professional for foundation model development.The ideal candidate will focus on gathering and generating high-quality text dat...Show more

 • Promoted

Manager, Statistical Programming (Remote)

AbbVieSouth San Francisco, CA, United States
Remote
Full-time

Company DescriptionAbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow.We strive to ...Show more

 • Promoted

Global AI Programs Lead: Coding & Data Analytics

UberSan Francisco, CA, United States
Full-time

A leading technology company is seeking a candidate to lead program delivery and client engagement within AI training and evaluations.The role involves engaging clients, managing program delivery, ...Show more

 • Promoted • New!

Quant Researcher (Factor Models)

Quantitative SystemsSan Francisco, CA, United States
Full-time +1

This range is provided by Quantitative Systems.Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.Seniority: 4 to 6 years experience.Tech Stack: Py...Show more