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Senior Statistical Programmer/Analyst Consultant – TA, Gene Therapy
ClinChoice. Lead statistical programming activities for Gene Therapy clinical trials from study start-up through database lock, analysis, and reporting .
About the role
Key responsibilities & impact- 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
Requirements
What you’ll need- 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
Benefits
Comp & perks- Professional development and training
- Supportive culture
- Close management and training
- Continuous training
- Equal opportunity and diversity/inclusivity commitment