ClinChoice - Principal Statistical Programmer /Analyst Consultant - Remote in US
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Requirements
• Bachelor’s or Master’s degree in Statistics, Computer Science, Mathematics, Life Sciences, or related field. • 8–12+ years of statistical programming experience in pharma/biotech or CRO. • 8–12+ years • Expert-level proficiency in SAS. • Strong understanding of CDISC SDTM and ADaM standards. • CDISC SDTM and ADaM • oncology clinical trials • Experience supporting regulatory submissions and preparing submission-ready outputs. • regulatory submissions • Excellent communication skills and ability to collaborate cross-functionally. • 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
• Technical Leadership • Lead programming activities for oncology clinical trials across multiple studies. • Develop, validate, and maintain SDTM and ADaM datasets following CDISC guidelines. • SDTM and ADaM datasets • Oversee production of Tables, Listings, and Figures (TLFs) for study reporting and submissions. • Tables, Listings, and Figures (TLFs) • Provide SAS programming expertise to support complex data derivations and analyses. • Review and ensure traceability, consistency, and quality of all programming deliverables. • Project & Study Management • Act as programming lead for assigned studies, managing timelines and deliverables. • Work closely with Biostatistics, Data Management, Medical Writing, and Regulatory Affairs. • Coordinate with CROs and external vendors, ensuring compliance, quality, and adherence to client programming standards. • Support integrated analyses including ISS/ISE. • ISS/ISE • Regulatory & Submission Support • Prepare submission-ready programming outputs and documentation, including define.xml, annotated CRFs, and reviewer guides. • Ensure all programming meets regulatory requirements (FDA, EMA, PMDA). • Contribute to responses for regulatory queries and data requests.
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