Senior Scientist, Statistical Programming

Merck & Co., Inc; United States; On-site; USD 120,000 - 160,000; Full time

Job summary

Merck & Co., Inc. seeks an experienced Statistical Programmer to support clinical trial data analysis and regulatory submissions. You will develop SAS programs to build and validate ADaM datasets and TFLs, following CDISC and ICH standards and SOPs.

You will collaborate with biostatisticians and project leads to ensure high-quality, timely deliverables and coordinate activities across a global programming team in a fast-paced environment.

Qualifications

• Master's degree or equivalent in Computer Science, Statistics, Applied Mathematics, Biomedical Engineering, or related field with 3 years of experience; OR Bachelor's with 5 years in related role.
• 3 years experience in developing analysis and reporting deliverables for Phase 2 and 3 trials (datasets, tables, graphics, listings).
• SAS programming in a clinical trial environment (data step, procedures, macros, graphics, ODS).
• Interpreting and executing on clinical trial statistical analysis plans.
• CDISC standards to create ADaM and SDTM datasets.
• Designing and developing complex programming algorithms and ensuring deliverable quality.

Responsibilities

• Support statistical programming activities for clinical trial data analysis.
• Develop SAS programs to create and validate ADaM datasets and TFLs for CRs and regulatory submissions.
• Collaborate with biostatisticians and project leads to ensure timely, high-quality deliverables.
• Develop study/programming and validation using global CDISC, ICH standards and SOPs.
• Maintain project plans and coordinate activities of a global programming team.

Skills

ADaM/SDTM datasets

SAS programming

Phase 2/3 analyses

CDISC standards

Programming algorithms

deliverable quality

Education

Master's degree or equivalent in CS/Stats/Applied Math/Biomedical Eng

Bachelor's degree plus 5 years experience

Job description

Responsibilities

• Support statistical programming activities for clinical trial data analysis.
• Develop SAS programs to create and validate analysis datasets (ADaM) and summaries (TFLs) in support of Clinical Study Reports and regulatory submissions (FDA, EMA, etc.).
• Collaborate with biostatisticians, project leads, and other stakeholders in ensuring project plans are executed efficiently with timely and high-quality deliverables.
• Develop effective study and report programming and validation utilizing global CDISC, ICH, and Therapeutic Areas standards and following departmental SOPs and good programming practices.
• Maintain and manage a project plan including resource forecasting. Coordinate activities of a global programming team. Participate in departmental strategic initiative teams.

Requirements

• Master's degree or equivalent in Computer Science, Statistics, Applied Mathematics, Biomedical Engineering, or a closely related field and 3 years of experience in the position offered or a related role; OR a Bachelor's degree or equivalent in Computer Science, Statistics, Applied Mathematics, Biomedical Engineering, or a closely related field and 5 years of experience in the position offered or a related role.
• Must have 3 years of experience with all the following:
  • Developing analysis and reporting deliverables for Phase 2 and 3 clinical trials, including creation of analysis datasets, tables, graphics, and listings, for planned and unplanned analyses.
  • SAS programming in a clinical trial environment including data step and procedures, macros, graphics, ODS.
  • Interpreting and executing on clinical trial statistical analysis plans.
  • Utilizing CDISC standards to create ADaM and SDTM datasets.
  • Designing and developing complex programming algorithms.
  • Ensuring process compliance and deliverable quality.

Required Skills

Preferred Skills

US and Puerto Rico Residents Only

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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.

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

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: No relocation
• VISA Sponsorship: No
• Travel Requirements: No Travel Required
• Flexible Work Arrangements: Not Applicable
• Shift: Not Indicated
• Valid Driving License: No
• Hazardous Material(s): n/a

Job Posting End Date: 08/19/2026

*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: R395927