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.
We are seeking an experienced
Senior Statistical Programmer with strong expertise in clinical trial programming and a solid background in
oncology. The successful candidate will be capable of independently leading statistical programming activities across clinical studies, partnering closely with statisticians, clinical teams, and other cross-functional stakeholders.
This role requires strong technical expertise in
SAS programming, CDISC standards, and clinical trial reporting, along with the ability to take ownership of programming deliverables and provide guidance to junior team members.
Key Responsibilities- Lead statistical programming activities for clinical studies within the oncology therapeutic area, from study start-up through database lock, analysis, and reporting.
- Develop, review, and maintain high-quality SAS programs for SDTM, ADaM, Tables, Listings, and Figures (TLFs).
- Lead programming activities for interim and final analyses, including complex efficacy and safety analyses.
- Work closely with Biostatisticians to understand statistical analysis plans, programming specifications, and study requirements.
- Develop and review programming specifications and ensure consistency with study 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.
- Perform independent programming validation and quality control of statistical outputs and datasets.
- Support submission-related activities and respond to programming and data-related queries from cross-functional and regulatory teams.
- Identify potential programming issues and proactively communicate risks, timelines, and solutions to project stakeholders.
- Coordinate programming activities across studies and ensure deliverables are completed within agreed timelines and quality standards.
- Provide technical guidance and mentorship to Statistical Programmers and other programming team members.
- Participate in client/project meetings and effectively communicate technical information to both technical and non-technical stakeholders.
Required Qualifications- Bachelor's or Master's degree in Statistics, Biostatistics, Mathematics, Computer Science, or a related field.
- Strong experience in clinical trial statistical programming, preferably within a CRO, pharmaceutical, or biotechnology environment.
- Significant experience working on oncology clinical trials.
- Basic or working knowledge of R programming is preferred.
- Experience supporting regulatory submissions
- Strong proficiency in SAS programming, including Base SAS and relevant SAS 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.
The Application ProcessOnce 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.
Who will you be working for?#LI-TT1 #LI-Remote #senior#contract
