Lead Statistical Programmer Job at cGxPServe, Irvine, CA

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  • cGxPServe
  • Irvine, CA

Job Description

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.

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