Senior Scientist, Patient-Centered Endpoints & Strategy (PaCES)
Senior Scientist, Patient-Centered Endpoints & Strategy (PaCES)
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$ 114700 - 180500
1 Vacancy
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 Companys 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:
Masters 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 Bachelors 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
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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 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
$114700.00 - $180500.00This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employees 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 can apply for this role through (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
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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:
RegularRelocation:
No relocationVISA Sponsorship:
NoTravel Requirements:
10%Flexible Work Arrangements:
HybridShift:
Not IndicatedValid Driving License:
NoHazardous Material(s):
n/aRequired Skills:
Biopharmaceutical Industry Data Management Investigator Meetings Methods and Tools Outcome Measures Patient Reported Outcomes Project Management Researching Reviewing Literature Work CoordinationPreferred 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.
Required Experience:
Senior IC
Employment Type
Full-Time
