Statistical Programmer - Clinical

Role Overview: As a Lead Statistical Programmer, you will be responsible for overseeing programming activities for clinical trials, regulatory submissions, and integrated analyses. Your role will involve leading a team, ensuring high-quality deliverables, and developing efficient programming standards to support drug development. Key Responsibilities: - Lead statistical programming activities for a compound or therapeutic area. - Manage, mentor, and guide a team of statistical programmers. - Create and validate analysis data sets (ADaM), tables, listings, and figures (TFLs) following CDISC standards. - Develop and validate Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE) reports. - Ensure accuracy and consistency across clinical studies and integrated data. - Develop, test, and implement reusable standard programs and SAS macros to automate routine tasks. - Prepare reviewer guides, data definition documents, and other materials for regulatory filings. - Collaborate with cross-functional teams including Statisticians, Clinical Data Management, Medical Writing, Regulatory, and Clinical Operations. - Accurately estimate programming efforts and ensure timely project delivery. Qualification Required: - Strong proficiency in SAS programming; experience with R preferred. - In-depth knowledge of CDISC standards (ADaM, SDTM). - Experience with regulatory submissions (FDA, EMA) and clinical study lifecycle. - Knowledge of therapeutic areas such as Oncology, Immunology, Neuroscience. - Strong communication and leadership skills to guide teams and manage stakeholders. - Ability to handle multiple priorities and deliver high-quality results under deadlines.,