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Provide oversight and quality management of submission data standard deliverables
Plan and coach project teams on submission data standards
Consult with external vendors and partners
Keep current with industry submission data standards
Improve electronic submission process and provide tools and templates

Requirements

BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field
MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field
Nice to have: R programming
Nice to have: Python programming
Nice to have: SOPs

Skills

SAS programming CDISC SDTM CDISC ADaM Define.XML cSDRG

Senior Scientist, Statistical Programming - SDTM

MSD · Posted Nov 10, 2026

Open

Pennsylvania, United States
Hybrid
Full-time · Senior
$117K–$184K per year
5+ years

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Senior Statistical Programmer overseeing submission data standards quality management for global drug and vaccine regulatory submissions.

Compensation

$117,000.00 - $184,200.00

Responsibilities

Provide oversight and quality management of submission data standard deliverables
Plan and coach project teams on submission data standards
Consult with external vendors and partners
Maintain current knowledge of SDTM, ADaM, and other CDISC standards
Improve electronic submission processes and provide tools and templates

Requirements

BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field
MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field
Nice to have: R programming
Nice to have: Python programming
Nice to have: reporting processes

Skills

SAS programming CDISC SDTM CDISC ADaM Define.XML cSDRG

Clinical Data Standards Lead -M/F- CDI

Pierre Fabre Laboratories · Posted Nov 9, 2026

Open

Haute Garonne, France
On-site
Full-time · Senior
10+ years

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Lead the definition, implementation and governance of Pierre Fabre's Clinical Data Standards Strategy, including the CDISC-based sponsor standards library.

Responsibilities

Lead the definition, implementation and governance of Pierre Fabre's Clinical Data Standards Strategy.
Own and evolve the Pierre Fabre Sponsor Standards Library built on top of CDISC standards.
Establish standards governance processes, lifecycle management, version control and change management practices.
Lead the development, maintenance and governance of standards covering eCRF libraries, SDTM, ADaM, edit checks, controlled terminology and study metadata.
Ensure Pierre Fabre standards remain aligned with evolving regulatory expectations and industry best practices.

Requirements

Master's Degree or PhD in life sciences, data management, statistics, programming or a related field

Skills

clinical trials oncology eCRF/CDASH SDTM ADaM controlled terminology

Pr. Statistical Programmer (Clinical Pharmacology)

Pr. Statistical Programmer (Clinical Pharmacology)

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Senior Scientist, Statistical Programming - SDTM (Hybrid)

Compensation

Responsibilities

Requirements

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Senior Scientist, Statistical Programming - SDTM

Compensation

Responsibilities

Requirements

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Clinical Data Standards Lead -M/F- CDI

Responsibilities

Requirements

Skills

Benefits

Benefits

DEFINE.XML jobs

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