Job
Description
Company Description ClinFocus empowers life sciences organizations to accelerate clinical trials through technology-driven solutions. Our services include EDC Development, Systems Integration, AI Deployment & Enablement, Clinical Data Science, Project Management, and Development of Integrated Dashboards. As an ISO-certified organization and partner of Medidata Rave, we are committed to excellence and trust in clinical research. We are seeking a highly motivated and skilled Clinical Statistical Programmer to join our dynamic Biometrics team. In this role, you will be instrumental in the development, validation, and maintenance of programs used for the analysis and reporting of clinical trial data. You will work closely with biostatisticians, data managers, and clinical scientists to ensure the accurate and timely delivery of high-quality statistical outputs. Responsibilities: Develop, validate, and maintain SAS programs for the creation of SDTM and ADaM datasets, tables, listings, and figures (TLFs) according to statistical analysis plans (SAPs) and programming specifications. Ability to contribute to the development and implementation of Statistical Analyses Plan Perform quality control (QC) of programs and outputs generated by other statistical programmers to ensure accuracy, consistency, and adherence to company standards and regulatory guidelines. Collaborate with biostatisticians to clarify programming requirements, resolve data issues, and ensure the accurate implementation of statistical methodologies. Contribute to the development and review of programming specifications, mock TLFs, and other study-related documentation. Ensure compliance with regulatory requirements (e.g., FDA, EMA, ICH-GCP) and internal Standard Operating Procedures (SOPs). Participate in team meetings and contribute to discussions regarding study design, data analysis, and reporting strategies. Proactively identify and implement process improvements to enhance efficiency and quality of programming deliverables. Maintain comprehensive documentation of programming activities and version control. May contribute to the development and maintenance of programming standards and macros. Qualifications: Bachelor's or Master's degree in Statistics, Biostatistics, Computer Science, Mathematics, or a related scientific field. Minimum of3] years of experience in clinical statistical programming within the pharmaceutical, biotechnology, or CRO industry. Proficiency in SAS programming (Base SAS, SAS/STAT, SAS/GRAPH, SAS Macro Language). Strong understanding of CDISC standards, including SDTM and ADaM. Experience with regulatory submissions (e.g., NDA, BLA) is highly desirable. Solid understanding of clinical trial processes, ICH-GCP guidelines, and relevant regulatory requirements. Excellent attention to detail and strong problem-solving skills. Ability to work independently and as part of a collaborative team. Strong written and verbal communication skills. Experience with other programming languages (e.g., R, Python) is a plus. Knowledge of industry best practices for statistical programming. What We Offer: Opportunity to work on innovative clinical trials across diverse therapeutic areas. A collaborative and supportive work environment. Opportunities for professional growth and development. Competitive salary and benefits package. Show more Show less
