ClinChoice - Senior Statistical Programmer/Analyst Consultant (Need solid oncology background) Remote in US
Requirements
• Bachelor's or Master's degree in Statistics, Biostatistics, Mathematics, Computer Science, or a related field. • Statistics, Biostatistics, Mathematics, Computer Science, or a related field • Strong experience in clinical trial statistical programming, preferably within a CRO, pharmaceutical, or biotechnology environment. • clinical trial statistical programming • 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. • SAS programming • Strong knowledge of CDISC standards, particularly SDTM and ADaM. • CDISC standards • 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 Process • Once 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? • ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. • Our Company Ethos • Our Company Ethos • Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates.
Responsibilities
• Lead statistical programming activities for clinical studies within the oncology therapeutic area, from study start-up through database lock, analysis, and reporting. • oncology therapeutic area • Develop, review, and maintain high-quality SAS programs for SDTM, ADaM, Tables, Listings, and Figures (TLFs). • 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. • 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.
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