Data Science Leader - Clinical Trials

Job Title: Senior Statistical Programmer Overview The role of a Senior Statistical Programmer is to provide leadership and expertise in statistical programming support for clinical trial data analysis and regulatory submissions. Key Responsibilities: Author and validate documents, including SAS programs, datasets, TFLs, and macros, ensuring adherence to good programming practices. Develop and maintain programs using R with hands-on experience in relevant packages, such as the tidyverse and Admiral. Create ADAM datasets using Admiral packages and R. Read and write raw data across SAS and R platforms. Conduct thorough debugging using R console tools. Review and approve clinical trial documents and dataset specifications, including TFL shells. Identify and resolve data issues, outliers, and standards-related discrepancies. Complete and review CDISC validation tool reports. Stay updated on emerging CDISC standards and assess their impact on ongoing and future trials. Maintain proficiency in SAS and awareness of developments in programming tools and standards. Ensure study master file documents are audit-ready. Serve as lead programmer for client accounts and projects, managing client expectations and issue resolution. Provide input and review project management documents. Perform work in full compliance with applicable legislation, regulations, company policies, and procedures. Actively contribute to internal client study team meetings. Qualifications and Skills: Bachelor's or Master's degree in statistics, computer science, or a related field. Proven experience in SAS programming for clinical trials and pharmaceutical settings. Strong hands-on experience in R programming with relevant packages. Knowledge of CDISC standards, ADAM, SDTM, and regulatory submission requirements. Excellent problem-solving, debugging, and data validation skills. Strong communication skills for managing client interactions and cross-functional collaboration. Ability to work independently and lead project teams. Preferred Experience: Exposure to regulatory submissions and audit processes. Experience as a lead programmer, managing timelines, deliverables, and client relationships.

Apply Now