Principal Scientist, Statistical Programming – A&R Standards, Innovation

MSD

Principal Scientist in Biostatistics developing standards for drug and vaccine projects. Collaborating cross-functionally to drive analysis and reporting enhancements for global research.

Posted 5/20/2026full-timeNorth Wales • New Jersey, Pennsylvania • 🇺🇸 United StatesLead💰 $173,200 - $272,600 per yearWebsite

Tech Stack

Tools & technologies

Python

About the role

Key responsibilities & impact

Support the strategic design, development, and delivery of efficient, flexible, and modular analysis and reporting and submission standards and tools that can be used for drug and/or vaccine projects across all therapeutic areas.
Adheres to standard operating procedures and guidelines established by the department.
Drives data structures that include analysis and reporting data standards and submission standards.
Actively leads and contributes to the department's strategic initiatives.
Key collaborator with internal and external stakeholders including Biostatistics, Statistical Programming, Data Management, Clinical Research, Regulatory, Observational Research, Clinical Safety, and PK/PD Modeling and Simulation organizations.
Drive the development and adoption of scalable, reusable multilingual standards library based on R, Python and SAS with an emphasis on open-source adoption and automation, leveraging AI where appropriate.
Address operational challenges that require strategic standard-based solutions, resulting in improved analysis and reporting deliverables.
Facilitate global adoption of standards and programming best practices.
Provide technical consultation and analytical support to statistical programmers and statisticians.
Lead and actively contribute to departmental strategic initiative project teams.

Requirements

What you’ll need

BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 12 or more years statistical programming experience in a clinical trial environment OR MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 10 or more years statistical programming experience in a clinical trial environment
Excellent interpersonal skills and ability to negotiate and collaborate effectively.
Excellent written, oral, and presentation skills.
Superior knowledge and significant experience in setting strategy and developing analysis and reporting deliverables for R&D projects (data, analyses, tables, graphics, listings).
Excellent project management skills; leadership across multiple and complex programs; determines approach and ensures consistency and directs development of others when opportunities arise; ability to engage key stakeholders.
Expertise in clinical trial programming, including data manipulation, reporting workflows, visualization, and production-quality practices using multiple programming languages and tools.
Strong knowledge and understanding of CDISC SDTM and ADaM analysis dataset standards.
Demonstrated understanding of statistics, clinical trial, and data management concepts as applied to drug/vaccine development.
Strategic thinking - ability to analyze operational activities and challenges and develop and implement strategic solutions.
Ability and interest to work across cultures and geographies.

Benefits

Comp & perks

medical, dental, vision healthcare and other insurance benefits (for employee and family)
retirement benefits, including 401(k)
paid holidays
vacation
compassionate and sick days

ATS Keywords

✓ Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

statistical programmingdata manipulationreporting workflowsvisualizationproduction-quality practicesRPythonSASCDISC SDTMADaM

Soft Skills

interpersonal skillsnegotiationcollaborationwritten communicationoral communicationpresentation skillsproject managementleadershipstrategic thinkingcross-cultural communication

Certifications

BA/BS in Computer ScienceMS in Computer Science