[Remote] Statistical Programmer Consultant SDTM Expert
Note: The job is a remote job and is open to candidates in USA. Redbock, an NES Fircroft company, is a clinical-stage biotech organization based in the Bay Area seeking a Senior Statistical Programmer. This role will focus on CDISC SDTM standards, requiring expertise in SDTM mapping and implementation for oncology clinical trials, while providing support and technical guidance to cross-functional teams.
Responsibilities
ā¢ Lead the development, mapping, and implementation of CDISC SDTM datasets for oncology clinical studies
ā¢ Translate raw clinical data into compliant SDTM domains according to CDISC standards and sponsor requirements
ā¢ Develop and maintain SDTM specifications and mapping documentation
ā¢ Perform hands-on SAS programming to create, validate, and quality control SDTM datasets
ā¢ Ensure SDTM deliverables are submission-ready and compliant with regulatory standards
ā¢ Collaborate with Biostatistics, Data Management, and Clinical teams to resolve data and mapping issues
ā¢ Review CRFs, CRF annotations, and protocols to ensure accurate SDTM mapping
ā¢ Support regulatory submissions and respond to data-related queries as needed
Skills
ā¢ 10ā15+ years of statistical programming experience in clinical research, preferably with small to mid-sized sponsor companies
ā¢ Extensive expertise in CDISC SDTM standards with strong hands-on SDTM mapping and implementation experience for oncology trials
ā¢ Oncology experience required, with solid tumor experience strongly preferred (RECIST criteria)
ā¢ Advanced SAS programming skills with a focus on SDTM dataset creation and validation
ā¢ Experience preparing SDTM datasets for regulatory submissions (e.g., FDA/EMA)
ā¢ Ability to work independently and serve as an SDTM subject matter expert within the programming team
ā¢ Excellent communication skills and ability to collaborate effectively in a cross-functional environment
Company Overview
ā¢ Redbock is a consultancy that delivers customized resourcing solutions to pharmaceutical, biotechnology, medical device and diagnostics companies. It was founded in 2010, and is headquartered in Cupertino, California, USA, with a workforce of 51-200 employees. Its website is http://redbock.com/.
Company H1B Sponsorship
ā¢ Redbock - an NES Fircroft company has a track record of offering H1B sponsorships, with 8 in 2025, 5 in 2024, 1 in 2023, 1 in 2022, 8 in 2021, 9 in 2020. Please note that this does not guarantee sponsorship for this specific role.
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Responsibilities
ā¢ Lead the development, mapping, and implementation of CDISC SDTM datasets for oncology clinical studies
ā¢ Translate raw clinical data into compliant SDTM domains according to CDISC standards and sponsor requirements
ā¢ Develop and maintain SDTM specifications and mapping documentation
ā¢ Perform hands-on SAS programming to create, validate, and quality control SDTM datasets
ā¢ Ensure SDTM deliverables are submission-ready and compliant with regulatory standards
ā¢ Collaborate with Biostatistics, Data Management, and Clinical teams to resolve data and mapping issues
ā¢ Review CRFs, CRF annotations, and protocols to ensure accurate SDTM mapping
ā¢ Support regulatory submissions and respond to data-related queries as needed
Skills
ā¢ 10ā15+ years of statistical programming experience in clinical research, preferably with small to mid-sized sponsor companies
ā¢ Extensive expertise in CDISC SDTM standards with strong hands-on SDTM mapping and implementation experience for oncology trials
ā¢ Oncology experience required, with solid tumor experience strongly preferred (RECIST criteria)
ā¢ Advanced SAS programming skills with a focus on SDTM dataset creation and validation
ā¢ Experience preparing SDTM datasets for regulatory submissions (e.g., FDA/EMA)
ā¢ Ability to work independently and serve as an SDTM subject matter expert within the programming team
ā¢ Excellent communication skills and ability to collaborate effectively in a cross-functional environment
Company Overview
ā¢ Redbock is a consultancy that delivers customized resourcing solutions to pharmaceutical, biotechnology, medical device and diagnostics companies. It was founded in 2010, and is headquartered in Cupertino, California, USA, with a workforce of 51-200 employees. Its website is http://redbock.com/.
Company H1B Sponsorship
ā¢ Redbock - an NES Fircroft company has a track record of offering H1B sponsorships, with 8 in 2025, 5 in 2024, 1 in 2023, 1 in 2022, 8 in 2021, 9 in 2020. Please note that this does not guarantee sponsorship for this specific role.
Apply tot his job
Apply To this Job