Senior Scientist, Statistical Programming - SDTM (Hybrid)

MSD; North Wales (Montgomery County); On-site; USD 117,000 - 184,000; Full time

Job summary

Merck & Co., Inc. is seeking a Senior Statistical Programmer in the BARDS department to oversee submission data standard deliverables for global regulatory submissions.

The role emphasizes SDTM/ADaM standards, quality assurance, and collaboration with statistics, regulatory, and project stakeholders. Responsibilities include planning submission data standards, coaching teams, engaging with vendors, and driving continuous improvement of electronic submission processes.

Qualifications

• BA/BS or MS with SAS programming experience in clinical trials.
• Experience delivering SDTM/ADaM datasets and submission deliverables.
• Strong written, verbal, and presentation skills.

Responsibilities

• Oversee and quality-manage submission data standard deliverables for regulatory submissions.
• Coach project teams and coordinate with external vendors and partners.
• Improve electronic submission processes focusing on traceability and data fitness.

Skills

SAS programming

SDTM/ADaM knowledge

Regulatory submissions

Project coordination

Education

BA/BS 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

CDISC SDTM/ADaM

Define.XML

Job description

Job Description In BARDS (Biostatistics and Research Decision Sciences), a distinguished department within our 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.

Responsibilities

The Senior Statistical Programmer, Submission Data Standards Quality Management (SDSQM), provides oversight and quality management of submission data standard deliverables for world-wide regulatory application submissions of drug and vaccine clinical development projects.

Accountability predominantly includes submission data standards planning activities, coaching and consulting with project teams, outreach to external vendors and partners, and keeping current with industry submission data standards including SDTM, ADaM, clinical site data for CDER inspection planning, etc.

The incumbent will be responsible for continuous improvement of our electronic submission process and providing tools and templates to support delivery focusing on traceability, quality assurance, data conformance and data fitness.

The position is a key collaborator with statistical programming, statistics, regulatory and other project stakeholders.

Primary Activities

PreNDA and PreBLA meeting preparation, study data standards plan, preparing questions for FDA e-data mailboxes (CBER/CDER), attendance at meetings with regulatory agencies (FDA, EMA, PMDA). Guiding project teams preparing submission deliverables including use of Pinnacle 21 Enterprise. Up-versioning activities to specific versions of SDTM. Participation in industry teams and conferences on best practices. Membership on departmental strategic initiative project teams.

Education and Minimum Requirement

BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 5 years SAS programming experience in a clinical trial environment. MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 3 years SAS programming experience in a clinical trial environment.

Department Required Skills and Experience

Effective interpersonal skills and ability to negotiate and collaborate effectively. Effective written, oral, and presentation skills. Effective knowledge and experience in developing analysis and reporting deliverables for R&D projects (data, analyses, tables, graphics, listings). A project leader; completes tasks independently at a project level; ability to collaborate with key stakeholder. Position Specific Required Skills and Experience: US and/or worldwide drug or vaccine regulatory application submission experience including the development of electronic submission deliverables. Experience with submission standards CDISC (SDTM, ADaM), Define.XML, cSDRG, ADRG. Demonstrated success in the assurance of deliverable quality and process compliance. Excels in technical writing, able to convert complex ideas and information into simple readable form. Solid project management skills. Familiarity with clinical data management concepts. Strategic thinking - ability to turn strategy into tactical activities. Ability to anticipate stakeholder requirements.

Position Specific Required Skills and Experience

US and/or worldwide drug or vaccine regulatory application submission experience including the development of electronic submission deliverables. Experience with submission standards CDISC (SDTM, ADaM), Define.XML, cSDRG, ADRG. Demonstrated success in the assurance of deliverable quality and process compliance. Excels in technical writing, able to convert complex ideas and information into simple readable form. Solid project management skills. Familiarity with clinical data management concepts. Strategic thinking - ability to turn strategy into tactical activities. Ability to anticipate stakeholder requirements.

Preferred Skills and Experience

Hands-on experience with R and Python for data analysis and statistical modelling. Strong working knowledge of reporting processes (SOPs) and software development life‑cycle (SDLC). Experience assuring consistency across protocols and projects. 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

Clinical Data Interchange Standards Consortium (CDISC) Standards, Data Management, Data Modeling, Numerical Analysis, Stakeholder Relationship Management, Study Data Tabulation Model (SDTM), Waterfall Model

Preferred Skills

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. 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.

Primary Location

USA - Pennsylvania - Upper Gwynedd

Compensation and Benefits

Where required by law, the compensation range for this role is provided below. The salary range for the primary location of this role is: $117,000.00 - $184,200.00 This range reflects the Company's reasonable expectation of the base salary applicable to this role at the time of 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.

Additional Locations

Please note the salary range above applies to the Primary Location of the position. Where a role has other listed locations, different compensation guidelines may apply. You may find the salary ranges for additional locations below. If the salary range is not listed for the location you are applying to, our Talent Acquisition team will provide further information to you relevant to your location. Additional location(s) Compensation Information: 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: No Travel Requirements: 10% Flexible Work Arrangements: Hybrid Shift: Not Indicated Valid Driving License: No Hazardous Material(s): n/a

Job Posting End Date

Job Posting End Date: 11/30/2026 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.

Company Overview

Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.