Senior Scientist, Patient-Centered Endpoints & Strategy (PaCES)

MSD; Rahway (NJ); Hybrid; USD 114,000 - 181,000; Full time

Job summary

A leading biopharmaceutical company seeks a Senior Scientist to coordinate Clinical Outcomes Assessment strategies. This role involves collaboration across departments to validate and implement Patient-Reported Outcomes in clinical trials, requiring advanced education and significant industry experience.

Benefits

Comprehensive benefits package

401(k) retirement plan

Paid holidays and vacation

Qualifications

• 3+ years of relevant work experience for Master's or 5+ years for Bachelor's.
• Familiar with COA/PRO requirements for regulatory agencies.
• Strong project management and communication skills.

Responsibilities

• Coordinate global COA endpoint strategies and support the PaCES lead.
• Assist with COA/PRO instrument selection and validation.
• Conduct literature searches to support COA endpoint strategies.

Skills

Data Management

Project Management

Researching

Patient Reported Outcomes

Education

Master’s Degree in Health Services Research, Statistics, or Outcomes Research

Bachelor’s Degree in Health Services Research, Statistics, or Outcomes Research

Job description

Job Description

Under the general direction of the Sr Principal Scientist Patient-Centered Endpoints & Strategy (PaCES) lead, the Senior Scientist has responsibility for coordinating global Clinical Outcomes Assessment (COA) endpoint strategies, including Patient-Reported Outcomes (PROs) for specific disease areas. The individual will support the PaCES lead on the development, validation, analysis and interpretation of COA endpoints to support overall product development. The Senior Scientist will work closely with the PaCES lead to collaborate with individuals from Clinical Research, Regulatory Affairs, Biostatistics, Outcomes Research, and Operations to ensure COA endpoint strategies are consistent with and executed and interpreted to support the product strategy.

Primary activities include but are not limited to:

• Provide assistance on the selection and/or development of COA/PRO instruments for inclusion in studies

• Support the PaCES lead to provide guidance on implementing COA/PRO instruments into studies by following our Company's standard processes

• Attend Clinical Trial Team (CTT) meetings on behalf of the PaCES lead to facilitate alignment of the selection of an appropriate endpoint measure for inclusion in clinical trials

• Assist with coordination of COA/PRO related sections of evidence packages to be submitted to regulatory agencies

• Support the PaCES lead to coordinate the development, validation, implementation, and utilization of instruments aimed at measuring COA/PROs in the context of clinical trials and/or observational studies

• Conduct literature searches to support COA/PRO endpoint strategies

• Support and/or produce scientific communications (abstracts, poster presentations, podium presentations, manuscripts, etc.)

• Keep up to date with COA/PRO methodologies and guidelines (including those from regulatory authorities and reimbursement agencies) and communicate findings to the PaCES team

Qualifications

Education:

• Master’s Degree in Health Services Research, Statistics, Psychometrics, Outcomes Research or closely related field with 3+ years of relevant work experience in the pharma industry OR Bachelor’s Degree in Health Services Research, Statistics, Psychometrics, Outcomes Research or closely related field with 5+ years of relevant work experience in the pharma industry

Required Experience:

• Familiar with COA/PRO requirements for regulatory and reimbursement agencies

• Knowledge of methodological approaches and technical aspects (i.e. study design, data analysis and interpretation) of COA/PRO development, validation, electronic migration and interpretation into clinical trial and observational studies

• Ability to understand and respond to multiple internal and external customers

• Strong project management and communication skills

• Experience with scientific presentations and publications

BARDS2020

#eligibleforERP

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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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

$114,700.00 - $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. 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:

10%

Flexible Work Arrangements:

Hybrid

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

n/a

Required Skills:

Biopharmaceutical Industry, Data Management, Investigator Meetings, Methods and Tools, Outcome Measures, Patient Reported Outcomes, Project Management, Researching, Reviewing Literature, Work Coordination

Preferred Skills:

Job Posting End Date:

06/10/2025

*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.