Working remotely on a contract basis, the Contract Statistical Programmer will develop, validate, and maintain statistical programming deliverables for clinical studies and regulatory submissions while collaborating with cross-functional teams in a fast-paced biotech environment. Key responsibilities Develop, validate, and maintain SAS and/or R programs for SDTM, ADaM datasets, and TLFs in accordance with CDISC standards Support statistical analyses for safety reports, regulatory submissions, and other ad hoc reporting needs Ensure compliance with FDA regulations, GxP, and internal SOPs while performing quality control of statistical programs and outputs Required qualifications Master's degree in a quantitative field with 5+ years of relevant experience or a bachelor's degree with 8+ years of experience Strong proficiency in SAS and/or R for clinical trial data analysis and reporting Working knowledge of CDISC standards and regulatory submission requirements Experience producing TLFs and SDTM/analysis datasets in a pharmaceutical or biotechnology setting Familiarity with regulatory guidelines and GxP-compliant programming practices