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Austin | Expertini

Urgent! Lead Statistical Programmer in Austin | Katalyst HealthCares & Life Sciences | Expertini

Lead Statistical Programmer



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 , e-submission-ready packages, and work with tools such as Pinnacle 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 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 (, 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 , , 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.



  • Required Skill Profession

    Mathematical Science Occupations



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