Senior Scientist, Statistical Programming Full-time

Senior Scientist, Statistical Programming – Rahway, NJ

Support the centralized management of technology, platforms, inspections, and related process and training for the global Statistical Programming organization to ensure it operates in compliance with departmental and company SOPs, regulatory requirements, and standards.

Support the Business System Ownership (BSO) of platforms or applications and corresponding documents and training.

Work in partnership in managing, prioritizing, and implementing portfolio projects.

Drive compliance initiatives, change management and communication.

Support audit and inspections Center of Excellence with audits, inspections and CAPA (Corrective Action and Preventive Action) management.

Engage with operational staff and partners globally. Lead and actively contribute to departmental strategic initiative project teams.

Maintain SOPs, corresponding processes, assuring they are of high quality and complaint with regulatory requirements.

Education Requirements:

• Master's degree in Computer Science, Statistics, Applied Mathematics, Information Technology, Life Sciences, Engineering, or related field plus at least 2 years in a clinical trial environment (Analysis & Reporting, Information Technology, Data Management etc.) in the pharmaceutical industry, and at least 3 years SAS or R programming experience
• OR Bachelor's degree in Computer Science, Statistics, Applied Mathematics, Information Technology, Life Sciences, Engineering, or related field plus at least 5 years in a clinical trial environment (Analysis & Reporting, Information Technology (IT), Data Management etc.) in the pharmaceutical industry, and at least 3 years SAS or R programming experience.

Required Experience and Skills:

• Must have Business Analyst (BA) experience.
• Must possess comprehensive knowledge of reporting processes (SOPs) that align with regulatory requirements (e.g., 21 CFR Part 11, ICH GCPs) and software development life cycle (SDLC)
• Understanding of Statistical, Clinical, Medical Monitoring and Data Management concepts as applied to drug/vaccine development within the pharmaceutical industry; and broad knowledge of clinical trials processes, data structures and corresponding tools used to manage, extract, analyze & report data.
• Ability to anticipate stakeholder requirements
• Focus on customers
• Ability to listen to and address stakeholders' needs and concerns
• Ability and interest to work across cultures and geographies including partnering with statistical programming staff in AP and EU regions and offshore programming resources
• Demonstrated ability to communicate effectively across multiple audiences and clearly explain processes and system functionality to users; and demonstrated success in the assurance of deliverable quality and process compliance also required.
• Must possess effective interpersonal skills and ability to negotiate and collaborate effectively
• Written, oral, and presentation skills
• Knowledge and experience in developing analysis and reporting deliverables for R&D projects (data, analyses, tables, graphics, listings).
• Must be a project leader
• Possess the ability to complete tasks independently at a project level
• The ability to collaborate with key stakeholders.

The salary range for this role is

$114,700.00 to $180,500.00

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.

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.

U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday – Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

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:

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:

05/6/2026

*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.