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

Merck & Co.; North Wales (Montgomery County); Hybrid; USD 142,000 - 224,000; Full time

Job summary

Merck & Co. is seeking a senior statistical programming leader within BARDS to oversee analysis deliverables across late-stage drug and vaccine projects.

You will design and maintain datasets and generate safety and efficacy analyses, tables, listings, and figures for global submissions. The role requires extensive SAS expertise, CDISC/ADaM, and strong program management; you will coordinate a global programming team, mentor colleagues, and ensure timely, high-quality deliverables in a

Qualifications

• BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field with SAS programming in clinical trials (9+ years).
• MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field with SAS programming in clinical trials (7+ years).
• Excellent interpersonal, written, and presentation skills.
• Broad knowledge in developing analysis and reporting deliverables for R&D projects (data, analyses, tables, graphics, listings).
• Strong project management and leadership at the program level; ability to engage key stakeholders.

Responsibilities

• Lead effective analysis and report programming across global standards.
• Maintain project plans and forecast resources.
• Coordinate a global programming team including outsourced staff.
• Serve as the programming point of contact through the product lifecycle.
• Contribute to departmental strategic initiatives.

Skills

SAS programming

Clinical trial programming

Leadership

CDISC/ADaM

Regulatory submissions

Analytics concepts

GenAI tools

Project management

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

Microsoft Project

Outsourcing coordination

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.

This position leads statistical programming activities for multiple and/or late-stage drug/vaccine clinical-development projects. Accountability predominantly includes the development and execution of statistical-analysis and reporting deliverables (e.g. safety and efficacy analysis datasets, tables, listings, figures), the span of-which range from individual clinical trials to world-wide regulatory application submissions and post marketing-support.-

The incumbent is responsible for the design and maintenance of statistical datasets that support multiple-stakeholder groups which include clinical development, outcomes research and safety evaluation.-

The position is a key collaborator with statistics and other project stakeholders in ensuring that project plans are-executed efficiently with timely and high-quality deliverables.-

For assigned projects the position serves as the statistical programming point of contact and knowledge holder-through the entire product lifecycle.-

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 colleaguesAbility 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

BARDS2020

eligibleforERP

SPjobs

VETJOBS

EBRG

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. Please click here if you need an accommodation during the application or hiring process.

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:

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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 .

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

Search Firm Representatives Please Read Carefully-

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. -No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.-

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