Associate Principal Statistical Programmer, SDTM/ADaM QA

MSD; Northern (KY); Hybrid; USD 142,000 - 224,000; Full time

Benefits offered by this job

Medical, dental, vision

Job summary

Merck & Co. in Rahway, NJ, seeks an Associate Principal Scientist Statistical Programmer specializing in Submission Data Standards Quality Management.

You will oversee submission data standard deliverables for worldwide regulatory submissions and guide project teams in SDTM/ADaM implementation. The role focuses on continuous improvement of electronic submission processes, traceability, and data conformance, collaborating with regulatory, statistics, and project stakeholders across geographies.

Qualifications

• BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus SAS programming experience in a clinical trial environment.

Responsibilities

• Pre-NDA and Pre-BLA meeting preparation and questions for FDA data mailboxes.

Skills

Leadership at program level

Stakeholder management

Technical writing

Project management

SAS programming

Education

BA/BS in Computer Science, Statistics, Life Sciences, Engineering or related field

MS in Computer Science, Statistics, Life Sciences, Engineering or related field

Tools

Pinnacle 21 Enterprise

Define-XML

CDISC SDTM/ADaM

Job description

Merck & Co. in Rahway, NJ, seeks an Associate Principal Scientist Statistical Programmer specializing in Submission Data Standards Quality Management.

You will oversee submission data standard deliverables for worldwide regulatory submissions and guide project teams in SDTM/ADaM implementation. The role focuses on continuous improvement of electronic submission processes, traceability, and data conformance, collaborating with regulatory, statistics, and project stakeholders across geographies.