Senior Gene Therapy Statistical Programmer (Remote)

ClinChoice; United States; Remote; USD 120,000 - 170,000; Full time

Job summary

ClinChoice is seeking a Senior Statistical Programmer Consultant to lead gene therapy programming for client studies. You will design and execute SDTM/ADaM datasets, tables, listings and figures, and collaborate with biostatistics to interpret SAPs and study protocols.

You will mentor junior programmers, manage timelines, and ensure regulatory-ready outputs for CDISC standards, while delivering high-quality programming across the full study lifecycle.

Qualifications

• Bachelor's or Master's degree in Statistics, Biostatistics, Mathematics, Computer Science, or a related field.
• Significant experience in clinical trial statistical programming within a pharmaceutical, biotechnology, or CRO environment.
• Hands-on experience supporting Gene Therapy clinical trials is required.
• Strong proficiency in SAS programming.
• Strong knowledge of CDISC standards, including SDTM and ADaM.
• Experience developing and validating clinical trial TLFs.
• Ability to independently lead study-level programming activities.
• Understanding of clinical trial processes, statistical analysis, and regulatory reporting.
• Excellent analytical, communication, and problem-solving skills.

Responsibilities

• Lead statistical programming activities for Gene Therapy clinical trials from study start-up through database lock, analysis, and reporting.
• Develop, review, and validate SAS programs for SDTM, ADaM, Tables, Listings, and Figures (TLFs).
• Collaborate with Biostatisticians to interpret study protocols, SAPs, and programming specifications.
• Develop and validate clinical datasets and statistical outputs for safety and efficacy analyses.
• Support interim and final analyses, database lock activities, and Clinical Study Report preparation.
• Ensure programming deliverables comply with CDISC standards and applicable regulatory requirements.
• Perform independent validation and quality control of datasets, TLFs, and other programming outputs.
• Support regulatory submissions and address programming-related questions from internal and external stakeholders.
• Manage study-level programming timelines, deliverables, and quality expectations.
• Identify and resolve complex programming issues and proactively communicate risks.
• Provide technical guidance and mentorship to other Statistical Programmers.
• Participate in client-facing meetings and collaborate with cross-functional project teams.

Skills

SAS programming

CDISC SDTM/ADaM

Lead study-level programming

TLFs (Tables Listings Figures)

Gene Therapy experience

Education

Bachelor's or Master's in Statistics/ Biostatistics/ Mathematics/ Computer Science

Job description

ClinChoice is seeking a Senior Statistical Programmer Consultant to lead gene therapy programming for client studies. You will design and execute SDTM/ADaM datasets, tables, listings and figures, and collaborate with biostatistics to interpret SAPs and study protocols.

You will mentor junior programmers, manage timelines, and ensure regulatory-ready outputs for CDISC standards, while delivering high-quality programming across the full study lifecycle.