We are seeking an experienced Senior Statistical Programmer to provide advanced programming support for clinical studies and regulatory submissions. This individual will play a key role in developing and validating CDISC-compliant datasets, generating high-quality outputs, and supporting exploratory and ad-hoc analyses across multiple studies.
Key Responsibilities:
Provide programming support for clinical studies and regulatory submissions.
Develop and maintain programs to produce and validate CDISC-compliant SDTM and ADaM datasets, as well as datasets for ad-hoc and exploratory analyses.
Generate and validate tables, figures, and listings (TFLs) for publications, ad-hoc requests, and other deliverables.
Create and maintain detailed dataset specifications in accordance with SDTM IG, ADaM IG, and the Statistical Analysis Plan (SAP).
Develop, maintain, and optimize SAS macros and other utility programs to streamline workflows.
Design, develop, and test programming solutions to address complex business and technical requirements.
Collaborate closely with cross-functional teams, including biostatistics, data management, and clinical operations, to ensure accuracy, consistency, and timeliness of deliverables.
Manage multiple priorities effectively and consistently meet deadlines while maintaining high standards of quality.
Qualifications:
Bachelor’s or Master’s degree in Statistics, Computer Science, Mathematics, or a related field.
Pharmaceutical or biotechnology industry experience required (clinical trial experience preferred).
Advanced SAS programming skills with a strong understanding of clinical data structures.
Proven experience with CDISC SDTM and ADaM standards required.
Regulatory submission experience (e.g., FDA, EMA) strongly preferred.
Excellent verbal and written communication skills.
Experience with other statistical software (e.g., R, S-Plus, WinBUGS) a plus.
Familiarity with additional programming languages (Python, VBA, C++, etc.) preferred.
Strong attention to detail, problem-solving ability, and a proactive, collaborative mindset.
