Senior Specialist, Biostatistics

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

Benefits offered by this job

Healthcare benefits

401(k)

Job summary

Merck & Co., Inc. in Rahway, NJ seeks a skilled Statistical Programmer to develop, validate, and maintain statistical programs for clinical, operational, or research data. You will collaborate with statisticians, data managers and clinical teams to ensure high-quality, reproducible outputs.

Responsibilities include creating TLFs, validating data, and ensuring regulatory compliance. Strong SAS/R proficiency and 5+ years in pharma programming are required.

Qualifications

• Bachelor’s or Master’s degree in Statistics, Computer Science, or a related field.
• At least 5 years of experience in statistical programming in pharma, biotech, or CRO.
• Strong proficiency in SAS, R, and Excel.

Responsibilities

• Develop and validate statistical programs using SAS and R.
• Create analysis datasets, tables, listings, and figures (TLFs) according to study requirements and analysis plans.
• Support data cleaning, transformation, and quality control processes.
• Review study protocols and data specifications to ensure programming requirements are understood.
• Perform validation checks and ensure compliance with internal standards, SOPs, and regulatory guidelines.
• Collaborate with cross-functional teams including statisticians, data managers, project managers, clinical and regulatory teams.
• Troubleshoot programming issues and provide efficient solutions to support project timelines.
• Maintain clear documentation of programming code, processes, and deliverables.
• Contribute to process improvements and standardization of repetitive programming tasks.
• Participate the study team’s activities when needed.

Skills

Applied Statistics

Base SAS

Biostatistics

Data Analysis

Statistical Programming

Timeline Management

Waterfall Model

Education

Bachelor’s or Master’s degree in Statistics, Computer Science, or a related field

Tools

SAS

R

Excel

Job description

Job Description

Join Our Company’s Rahway Animal Health Team Our Company's Global Animal Health Research & Development (R&D) division is a pioneer in the discovery, development and registration of medicines, products, and therapeutics for animals. To strengthen the team responsible for our global initiatives, we are looking for a highly skilled and motivated individual to join our R&D team.

Position Summary

The Statistical Programmer is responsible for developing, validating, and maintaining statistical programs used in the analysis and reporting of clinical, operational, or research data. This role works closely with statisticians, data managers, and clinical teams to ensure high-quality, reproducible outputs that meet industry and regulatory standards.

Key Responsibilities

• Develop and validate statistical programs using statistical tools, SAS and R
• Create analysis datasets, tables, listings, and figures (TLFs) according to study requirements and analysis plans
• Support data cleaning, transformation, and quality control processes
• Review study protocols and data specifications to ensure programming requirements are understood
• Perform validation checks and ensure compliance with internal standards, SOPs, and regulatory guidelines
• Collaborate with cross-functional teams including statisticians, data managers, project managers, clinical and regulatory teams
• Troubleshoot programming issues and provide efficient solutions to support project timelines
• Maintain clear documentation of programming code, processes, and deliverables
• Contribute to process improvements and standardization of repetitive programming tasks
• Participate the study team’s activities when needed

Required Qualifications

• Bachelor’s or Master’s degree in Statistics, Computer Science, or a related field
• At least 5 years of experiences of statistical programming in pharma, biotech, or CRO.
• Strong proficiency in SAS, R, and Excel
• Good understanding of data structures, statistical methods, and analysis workflows
• Experience of leading programming activities
• Familiarity with regulatory requirements from agencies such as CVM/EMA/USDA
• Familiarity with Electronic Data Capture Systems, such as Prelude and/or Medrio are preferred

Required Skills

Applied Statistics, Base SAS, Biostatistics, Data Analysis, Numerical Analysis, Protocol Designing, Statistical Analysis, Statistical Computing, Statistical Packages, Statistical Programming, Timeline Management, Waterfall Model

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.

Equal Employment Opportunity

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

Salary

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.

Benefits

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.

Job Specifications

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

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

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.

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.