Senior Statistical Programmer — Submission Data Standards

Merck; North Wales (Montgomery County); On-site; USD 120,000 - 180,000; Full time

Job summary

Merck's BARDS department seeks an Associate Principal Statistical Programmer to oversee submission data standards for worldwide regulatory submissions. You will coach teams, coordinate with external vendors, and ensure SDTM/ADaM compliance and data fitness across trials.

The role emphasizes leadership in SDTM/ADaM deliveries, preparation for PreNDA/PreBLA, and engagement with FDA/EMA/PMDA meetings. Collaboration with cross-functional teams is essential for timely deliverables.

Qualifications

• BA/BS required with SAS programming experience in a clinical trial environment.
• MS preferred with SAS and regulatory submission experience.
• Strong knowledge of SDTM/ADaM standards and related deliverables.

Responsibilities

• Oversee submission data standard deliverables for regulatory submissions.
• Coach project teams and engage with vendors.
• Lead continuous improvement of electronic submission processes.
• Collaborate with statistics, regulatory and project stakeholders.

Skills

SAS programming

CDISC SDTM/ADaM

Project management

Stakeholder management

Technical writing

Data mapping

Regulatory submissions

Quality assurance

Education

Bachelor's degree 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

Tools

Pinnacle 21 Enterprise

Microsoft Project

Job description

Merck's BARDS department seeks an Associate Principal Statistical Programmer to oversee submission data standards for worldwide regulatory submissions. You will coach teams, coordinate with external vendors, and ensure SDTM/ADaM compliance and data fitness across trials.

The role emphasizes leadership in SDTM/ADaM deliveries, preparation for PreNDA/PreBLA, and engagement with FDA/EMA/PMDA meetings. Collaboration with cross-functional teams is essential for timely deliverables.