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 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:

• Masters degree in Statistics Biostatistics Computer Science or a related field.
• Minimum of 8 years of statistical programming experience in the pharmaceutical biotech or CRO environment.
• Expertise in SAS R CDISC standards and regulatory submission requirements.
• Deep understanding and hands-on experience with CDISC standards (SDTM ADaM) and regulatory submission requirements.
• Strong knowledge of statistical concepts clinical trial design data standards and regulatory expectations (e.g. FDA EMA PMDA).
• Proven ability to independently produce high-quality analysis datasets tables listings and figures for regulatory and publication purposes.
• Experience in working with tools like Pinnacle 21 and other clinical data standards tools.
• Demonstrated ability to collaborate effectively in cross-functional settings and manage competing priorities in a fast-paced or startup environment.