About The Position
ClinChoice is seeking a Senior Statistical Programmer Consultant to work directly with a client sponsor. This client-facing role calls for someone who can work independently and build a high-trust relationship with the client’s counterparts. The successful candidate will bring strong clinical trial programming expertise and a solid oncology background, lead programming activities across clinical studies, and partner with statisticians, clinical teams, and other cross-functional stakeholders. The role also includes taking ownership of programming deliverables and guiding junior team members. The consultant will use SAS and CDISC standards to develop and validate clinical trial datasets and reporting outputs, support interim and final analyses, and contribute to regulatory submissions. Responsibilities span study start-up through database lock, analysis, and reporting, with attention to quality, timelines, and effective communication with project stakeholders.
Requirements
- Bachelor’s or master’s degree in Statistics, Biostatistics, Mathematics, Computer Science, or a related field.
- Strong experience in clinical trial statistical programming, preferably in a CRO, pharmaceutical, or biotechnology environment.
- Significant experience working on oncology clinical trials.
- Experience supporting regulatory submissions.
- Strong proficiency in SAS, including Base SAS and relevant procedures used for clinical trial reporting.
- Strong knowledge of CDISC standards, particularly SDTM and ADaM.
- Experience developing and validating TLFs for clinical trials.
- Experience working with complex clinical trial data and supporting statistical analyses.
- Ability to independently manage programming deliverables and lead study-level programming activities.
- Strong understanding of clinical development processes, including protocols, SAPs, datasets, TLFs, and clinical study reports.
- Excellent communication, organizational, problem-solving, and collaboration skills.
Nice To Haves
- Basic or working knowledge of R programming.
Responsibilities
- Lead oncology clinical study programming from study start-up through database lock, analysis, and reporting.
- Develop, review, and maintain SAS programs for SDTM, ADaM, and tables, listings, and figures (TLFs).
- Lead programming for interim and final analyses, including complex efficacy and safety analyses.
- Collaborate with biostatisticians on statistical analysis plans, programming specifications, and study requirements.
- Develop and review programming specifications and ensure consistency with protocols, SAPs, and statistical methodology.
- Support the creation and validation of CDISC-compliant SDTM and ADaM datasets.
- Generate and validate TLFs for clinical study reports, regulatory submissions, and other clinical deliverables.
- Independently validate programming and perform quality control of statistical outputs and datasets.
- Support submission activities and respond to programming and data-related questions from cross-functional and regulatory teams.
- Identify programming issues and proactively communicate risks, timelines, and solutions to project stakeholders.
- Coordinate programming across studies and deliver work within agreed timelines and quality standards.
- Provide technical guidance and mentorship to Statistical Programmers and other programming team members.
- Participate in client and project meetings and communicate technical information to technical and non-technical stakeholders.
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What This Job Offers
Career Level
Senior
