Senior Statistical Programmer/Analyst Consultant (TA -Gene Therapy)-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

Senior Statistical Programmer/Analyst Consultant (TA -Gene Therapy)-Remote

United States

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….

ClinChoice is searching for a Senior Statistical Programmer Consultant to join one of our clients.

ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts.

We are seeking an experienced Senior Statistical Programmer with hands-on experience in Gene Therapy clinical trials to lead study-level statistical programming activities. The ideal candidate will have strong SAS programming expertise, a solid understanding of clinical trial data and regulatory requirements, and the ability to independently manage programming deliverables in collaboration with Biostatisticians and cross-functional teams.

Experience in Gene Therapy clinical development is essential. Experience in Oncology or Internal Medicine is also valuable.

Key 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, Statistical Analysis Plans (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.

Required 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.

Who will you be working for?

About ClinChoice

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates.

ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.