Senior Specialist, Biostatistics

Job Description

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

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

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.

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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.

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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:

09/28/2026

*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.