Senior Statistical Programmer/Analyst Consultant (Need solid oncology background) Remote in US
Clinchoice
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 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.
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