Lead Statistical Programmer

Company : Katalyst HealthCares & Life Sciences

Location : Irvine, CA, 92606

Posted Date : 9 October 2025

Job Type : Other

Category : Software Development

Occupation : Programmer

Job Details

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:

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.