Job Description

• 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.

• Master's 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, define.xml, 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.

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