Assoc Principal Scientist Statistical Programming, Late-Stage (Non-Oncology) (Hybrid)

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

Benefits offered by this job

Medical insurance

401(k) retirement benefits

Job summary

Merck in the United States (Rahway area) seeks a senior SAS programmer to lead statistical programming for BARDS within R&D. The role includes developing complex analysis deliverables, coordinating a global programming team, and ensuring compliant submissions to regulators.

Requirements include a BA/BS (or MS) in a related field and 7–9+ years of SAS experience in clinical trials. Hybrid work arrangements and a comprehensive benefits package are offered.

Qualifications

• BA/BS with 9+ years SAS programming in a clinical trial environment or MS with 7+ years.
• Strong knowledge of CDISC ADaM and regulatory submissions.
• Experience leading large programming projects and cross-functional teams.

Responsibilities

• Analyze and develop analysis deliverables and reports for R&D projects.
• Coordinate global programming team including outsource staff.
• Manage project plans with resource forecasting and SOP adherence.
• Provide technical guidance and mentoring to colleagues.

Skills

CDISC ADaM

CDISC Standards

Project Management

Regulatory Submissions

Stakeholder Relationships

SAS Programming

Education

BA/BS in CS/Stats/Math/Life Sciences/Engineering

MS in CS/Stats/Math/Life Sciences/Engineering

Tools

SAS/GRAPH

SAS Macro

SAS Data Steps

Job description

Job Description

In BARDS (Biostatistics and Research Decision Sciences), a distinguished department within our company's renowned Research and Development division, quantitative scientists, in partnership with other subject matter experts, apply state-of-the art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for the benefit of patients and global human health.

Primary Activities

• Effective analysis and report programming development and validation utilizing global and TA standards and
• Following departmental SOPs and good programming practices
• Maintain and manage a project plan including resource forecasting
• Coordinate the activities of a global programming team that includes outsource provider staff
• Membership on departmental strategic initiative teams

Education And Minimum Requirement

• BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus a minimum of 9 years SAS programming experience in a clinical trial environment
• MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus a minimum of 7 years SAS programming experience in a clinical trial environment

Department Required Skills And Experience

• Excellent interpersonal skills and ability to negotiate and collaborate effectively
• Excellent written, oral, and presentation skills
• Broad knowledge and significant experience in developing analysis and reporting deliverables for R&D projects (data, analyses, tables, graphics, listings)
• Strong project management skills; leadership at a program level; determines approach and ensures consistency and directs development of others when opportunities arise; ability to engage key stakeholders

Position Specific Required Skills And Experience

• Significant expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH; systems and database expertise
• Experience leading large and/or complex statistical programming projects that include coordinating the activities of a programming team
• US and/or worldwide drug or vaccine regulatory application submission experience at the leadership level including the development of electronic submission deliverables
• Designs and develops complex programming algorithms
• Ability to comprehend analysis plans which may describe methodology to be programmed; an understanding of statistical terminology and concepts
• Familiarity with clinical data management concepts
• Experience in CDISC and ADaM standards
• Demonstrated success in the assurance of deliverable quality and process compliance
• Strategic thinking - ability to turn strategy into tactical activities; design of statistical databases with the end in mind that optimize analysis and reporting and leverage departmental standards and industry best-practices
• Ability to anticipate stakeholder requirements
• Preferred Skills and Experience:
• Strong working knowledge of reporting processes (SOPs) and software development life-cycle (SDLC)
• Experience with GenAI tools (e.g., Python, R, R Shiny, Claude, etc.)
• Experience providing technical and/or programming guidance and mentoring to colleagues
• Ability and interest to work across cultures and geographies
• Ability to complete statistical programming deliverables through the use of global outsource partner programming staff
• Experience developing and managing a project plan using Microsoft Project or similar package
• Active in professional societies
• Experience in process improvement

Required Skills

CDISC ADaM, Clinical Data Interchange Standards Consortium (CDISC) Standards, Project Management, Regulatory Submissions, Stakeholder Relationship Management, Statistical Analysis Systems (SAS) Programming

Preferred Skills

Generative AI, Python (Programming Language), R Programming

US And Puerto Rico Residents Only

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities.

Requirements

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights

EEOC GINA Supplement

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts

The salary range for this role is

$142,400.00 - $224,100.00

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

The application deadline for this position is stated on this posting.

San Francisco Residents Only:

We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only:

We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

Employee Status

Regular

Relocation

Domestic

VISA Sponsorship

Yes

Travel Requirements

10%

Flexible Work Arrangements

Hybrid

Shift

Not Indicated

Valid Driving License

No

Hazardous Material(s)

n/a

Job Posting End Date

09/25/2026

• A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID:

R416557