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

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.

• 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.

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