Lead Statistical Programmer

Responsibilities :

• Serve as the principal programming lead across multiple studies or a clinical program, ensuring timely, accurate, and regulatory-compliant deliverables.
• Lead or contribute to the development, validation, and documentation of SDTM, ADaM, and TFLs in support of clinical study reports, regulatory submissions, publications, and ad-hoc requests.
• Collaborate closely with Biostatisticians, Data Management, and Clinical teams to review SAPs, TLF shells, and data specifications to ensure alignment and clarity.
• Provide expert input and review of programming assumptions, table shells, and analysis specifications.
• Support the preparation of define.xml, e-submission-ready packages, and work with tools such as Pinnacle 21 for compliance checking.
• Ensure programming deliverables meet regulatory standards and are consistent with CDISC and company-defined specifications.
• Oversee CRO deliverables as needed, with a focus on technical quality and consistency rather than operational management.
• Contribute to the development and optimization of programming standards, templates, and macros to improve team efficiency and quality.
• Collaborate with leadership on the design and enhancement of the Statistical Computing Environment (SCE), including folder structures, version control, and access management.
• Evaluate and implement innovative tools and programming technologies to streamline processes.

Requirements :