About The Position
ClinChoice is seeking a Senior Statistical Programmer Consultant to work directly with a client sponsor while employed within a global CRO. This client-facing role requires the ability to work independently and build a high-trust relationship with the client’s counterparts. The position leads study-level statistical programming activities for Gene Therapy clinical trials, collaborating with Biostatisticians and cross-functional teams from study start-up through database lock, analysis, and reporting. Experience in Gene Therapy clinical development is essential; experience in Oncology or Internal Medicine is valuable.
Requirements
- 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.
- 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.
Nice To Haves
- Experience in Oncology or Internal Medicine.
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.
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What This Job Offers
Career Level
Senior
