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

About the role

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.

The Application Process

• Once you have submitted your CV, you will receive an acknowledgement that we received it.
• If you have the requirements we need, you will be invited for phone interview as the first step.
• Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.