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Data Systems Senior Scientist/Sr. Specialist - Regulatory Affairs

Merck

Merck

Compliance / Regulatory
Pennsylvania, USA
USD 104,200-163,900 / year
Posted on Sep 16, 2025

Job Description

Job Description

Data Systems Senior Scientist (P3), Regulated Bioanalytics, Integrated Logistics & Sample Management (ILSM)

Description

The PDMB Regulated Bioanalytics Department is seeking a Data Systems Senior Scientist to join our Integrated Logistics and Sample Management group. This role will support work across groups within the Regulated Bioanalytics Department, including work at our Company's new state-of-the-art AdVAnce GxP research facility in West Point, PA. At this new facility, we will combine the power of innovative robotics, IT platforms, and science to accelerate vaccines and enable late-stage clinical trials through the generation of timely, high-quality regulated bioanalytical data. As the AdVAnce facility will not be fully constructed and ready for occupancy until 2026, initial roles will complete training and perform work primarily at our Company's Springhouse Innovation Park facility in Lower Gwynedd Township, PA.

The primary role of the successful candidate will be to provide data management and automated solutions to support the development and implementation of tools to increase the efficiency of processes, data review, and data visualization that can be applied to increase the throughput of our Vaccines pipeline. The individual should have demonstrated experience in applying software solutions to address scientific challenges and enhance productivity.

Education Minimum Requirement

PhD in Biological Sciences, Biomedical Engineering, Data Sciences, Computer Science or related area, or an MS degree with 2+ years, or BS degree with 4+ years of relevant experience

Responsibilities

  • Represents ILSM in early/late vaccine development teams and influences data strategies together with stakeholders

  • Communicates results effectively in presentations to stakeholders in partner organizations or at external scientific meetings, to write technical reports, and to participate on cross-functional teams

  • Provides scientific input of strategy, development, and validation of IT solutions for visualization tools for the review of experimental data and for IT tools used to track material through automated systems

  • Designs, assesses, and implements novel approaches and technology for data management, bioanalytical systems, data insight tools, and other applications required during non-clinical and clinical bioanalytical testing.

  • Benchmarks current approaches/techniques to the industry standards

  • Remains current in the field and maintains an external presence in the field of data management

  • Identifies opportunities for new collaborations, engages collaborators, identifies business needs and values, and proposes proper solutions

Required Experience & Skills

  • Understanding of statistical methods to analyze and visualize large data sets

  • Experience in algorithm development and implementation

  • Experience with software visualization programs

  • Knowledge and hands-on experience in areas such as discrete mathematics, constrained multi-objective optimization, dynamical modeling and simulation, machine learning, pattern recognition, data mining, and statistics

  • Familiarity with computer control concepts to assist in troubleshooting and implementing computer-based lab automation and instrumentation

  • Excellent oral and written communication skills; ability to work independently and collaborate with stakeholders to implement data strategies that enhance efficiency

  • Strong ability to deliver complex objectives under aggressive timelines in a rapidly changing environment

  • Working knowledge of regulatory and industry guidelines in the area of bioanalytical testing, preferably in the vaccines field

Preferred Experience & Skills

Project management skills

#ProjectADVANCE

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:

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

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”.

The salary range for this role is

$104,200.00 - $163,900.00

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:

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

Required Skills:

Adaptability, Adaptability, Algorithmic Design, Audits Compliance, Biochemical Tests, Biomedical Engineering, Clinical Testing, Communication, Computer Science, Data Visualization, Detail-Oriented, Discrete Mathematics, Drug Regulatory Affairs, Employee Training Programs, Global Communications, Management Process, Pattern Recognition, Pharmaceutical Regulatory Affairs, Pharmacovigilance, Process Improvements, Project Management, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Compliance, Regulatory Operations {+ 5 more}

Preferred Skills:

Job Posting End Date:

10/1/2025

*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:R365716