Senior Statistical Programmer

Merck; Rahway (NJ); Hybrid; USD 117,000 - 184,000; Full time

Job summary

Merck & Co., Inc. in Rahway, NJ, is seeking a senior statistical programmer to deliver high-quality programming for global stakeholders in early development statistics and PK/PD modeling.

The role focuses on data transformation, analysis datasets, and results delivery per analysis plans, collaborating with statisticians and PK modelers across therapeutic areas. You will develop and maintain datasets, tables, listings and figures, ensure traceability, and support regulatory submissions while

Qualifications

• BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 5-9 years SAS/R programming experience in a clinical trial environment.
• MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 3-7 years SAS/R programming experience in a clinical trial environment.
• Effective interpersonal, written, oral and presentation skills.
• Project leader; able to work independently at a project level and collaborate with stakeholders.

Responsibilities

• Programmatically develop, validate and maintain complex datasets, tables, listings, and figures.
• Provide technical consultation and analytical support to statisticians and PK modelers for exploratory analyses.
• Prepare compliant programming code for regulatory submissions including datasets, tables, listings and figures.
• Ensure programmatic traceability from data source to analysis results.
• Support development of programming standards for efficient production of deliverables.

Skills

CDISC SDTM/ADaM

SAS/R programming

Programming algorithms

Analysis plans understanding

Exploratory data analysis

Education

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

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

Tools

SAS

R

Python

Job description

Job Description

This position provides high quality statistical programming deliverables for global stakeholders in Early Development Statistics and/or PK/PD Modeling and Simulation spanning all our Company's therapeutic areas. The senior statistical programmer will gather and interpret user requirements for programming requests, retrieve required data, transform data into analysis/modeling datasets, and develop tables, listings and figures according to statistical/modeling analysis plan. The senior programmer will partner with stakeholders to solve problems; reduce the amount of programming tasks being completed by stakeholders to facilitate an increase in efficiency and compliance for the analyses. The senior programmer will also write programs to analyze data with statistical methods which are not currently available through commercial software packages. The programmer will be a key collaborator with statisticians, pharmacokinetic (PK) modelers, and other project stakeholders.

Responsibilities

This position provides high quality statistical programming deliverables for global stakeholders in Early Development Statistics and/or PK/PD Modeling and Simulation spanning all our Company's therapeutic areas. The senior statistical programmer will gather and interpret user requirements for programming requests, retrieve required data, transform data into analysis/modeling datasets, and develop tables, listings and figures according to statistical/modeling analysis plan. The senior programmer will partner with stakeholders to solve problems; reduce the amount of programming tasks being completed by stakeholders to facilitate an increase in efficiency and compliance for the analyses. The senior programmer will also write programs to analyze data with statistical methods which are not currently available through commercial software packages. The programmer will be a key collaborator with statisticians, pharmacokinetic (PK) modelers, and other project stakeholders.

Primary Activities

• Programmatically develop, validate and maintain complex datasets, tables, listings, and figures
• Provide technical consultation and analytical support to statisticians and PK modelers for exploratory and unplanned statistical analyses
• Prepare compliant programming code for regulatory submissions including analysis datasets, tables, listings, figures and associated documentation
• Ensure programmatic traceability from data source to analysis / modeling result
• Support the development of programming standards to enable efficient and high quality production of programming deliverables

Education and Minimum Requirement

• BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 5-9 years SAS/R programming experience in a clinical trial environment
• MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 3-7 years SAS/R 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 research and development projects (data, analyses, tables, graphics, listings)
• A project leader; completes tasks independently at a project level; ability to collaborate with key stakeholders

Specific required skills and experience

• Experience in CDISC SDTM and ADaM standards
• Significant SAS or R programming experience for data manipulation, analysis and reporting
• Designs and develops complex programming algorithms
• Ability to comprehend analysis plans which may describe methodology to be programmed; understanding of statistical terminology and concepts; Implements statistical methods not currently available through commercial software packages
• Demonstrated ability to work in an exploratory environment, handling non-standard data in a variety of formats with minimal requirements; knowledge of pharmaceutical development processes

Preferred skills and experience

• Programming expertise with pharmacokinetic data (raw concentration data, derived PK parameters)
• Familiarity with clinical pharmacology concepts and pharmacokinetics concepts
• Efficiently manipulates very large databases including complex data preprocessing, filtering, and manipulation; programming expertise with clinical endpoint data (efficacy and safety) and pharmacokinetic data (raw concentration data, derived PK parameters)
• Experience with at least one other software than SAS (e.g., R, Python, NonMem)
• Good working knowledge of reporting processes (SOPs) and software development life-cycle (SDLC)
• Utilizes and contributes to the development of standard departmental SAS macros
• Ability and interest to work across cultures and geographies
• Ability to complete statistical programming deliverables through the use of global outsource partner programming staff
• Active in professional societies

Required Skills

Clinical Database Programming, Clinical Trials, Collaborative Development, Data Modeling, Pharmaceutical Development, Project Leadership, Stakeholder Relationship Management, Statistical 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.

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:

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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

$117,000.00 - $184,200.00

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

10/2/2026

• 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

R406131