Lead Statistical Programmer - Submission Data Standards & QA

Merck & Co.; Rahway (NJ); Hybrid; USD 142,000 - 224,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

401(k) plan

Paid holidays & vacation

Job summary

HireLifeScience seeks an Associate Principal Statistical Programmer for SDS QM to oversee and improve submission data standards for global regulatory submissions. You will coach teams, liaise with FDA/EMEA/PMDA, and ensure data conformance and traceability across SDTM and ADaM deliverables.

Key responsibilities include planning, coaching, and contributing to governance initiatives while guiding external vendors and internal stakeholders toward high-quality, timely deliverables.

Qualifications

• US and worldwide drug or vaccine regulatory submission leadership experience.
• Strong knowledge of CDISC SDTM/ADaM standards and related deliverables.
• Ability to translate complex technical concepts into clear documentation.

Responsibilities

• Prepare submission data standards plans and questions for regulatory meetings.
• Guide teams in producing SDTM/ADaM deliverables and Define-XML.
• Oversee versioning of SDTM and contribute to governance discussions.
• Collaborate with regulatory, statistics, and programming groups worldwide.

Skills

SAS programming

Statistical programming

Regulatory submissions

SDTM/ADaM knowledge

Project management

Leadership

Stakeholder management

Communication skills

Quality assurance

Data mapping

Documentation

Data conformance

Requirements gathering

Traceability

SDLC

Strategic thinking

Standards governance

GenAI & automation

Vendor leadership

Education

BA/BS in Computer Science/Statistics/Applied Math/Life Sciences/Engineering

MS in Computer Science/Statistics/Applied Math/Life Sciences/Engineering

Tools

Pinnacle 21 Enterprise

Define-XML/SDRG/ADRG

CDISC SDTM/ADaM standards

Job description

HireLifeScience seeks an Associate Principal Statistical Programmer for SDS QM to oversee and improve submission data standards for global regulatory submissions. You will coach teams, liaise with FDA/EMEA/PMDA, and ensure data conformance and traceability across SDTM and ADaM deliverables.

Key responsibilities include planning, coaching, and contributing to governance initiatives while guiding external vendors and internal stakeholders toward high-quality, timely deliverables.