Job Description

Under the general direction of the Patient-Centered Endpoints & Strategy (PaCES) group lead, the Principal Scientist has responsibility for supporting or co-leading global Clinical Outcomes Assessment (COA) endpoint strategies, including Patient-Reported Outcomes for specific disease areas. The individual will co-lead or guide teams on the development, validation, analysis and interpretation of COA endpoints to support regulatory submissions, reimbursement evidence dossiers, payer interactions, and publications. The Principal Scientist will work closely 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:

• Collaborate in global COA endpoint strategic plans with Early Development Teams, Value & Implementation and Clinical Sub-teams to assure alignment with product franchise goals

• Execute and standardize COA-related activities including

• Coordinate and lead the development, validation, analysis, interpretation and utilization of instruments aimed at measuring COAs in the context of clinical trials and/or observational studies

• Provide guidance, create and/or review dossiers to be submitted to Regulatory Authorities and/or Health Technology Assessment (HTA) agencies to assure consistency and alignment with COA strategies and represent our company during these interactions

• Provide guidance on sections of protocols, analysis plans and reports related to COAs

• Work closely with the cross-functional study team to interpret results from COA endpoints

• Collaborate on quantitative analyses of COA data to inform endpoint strategies and produce development

• Maintain awareness of scientific, regulatory, and market access developments within their areas of expertise across our company's functional areas, both in terms of new methodology and new activities to establish communication with key outcomes research opinion leaders

• Organize the collection of existing information on COAs used in both internal and external studies to facilitate selection and/or development of measures

• Provide training on COA-related company groups, as needed

• Support or produce scientific communications (abstracts, poster presentations, podium presentations, manuscripts, etc.) and external communications (e.g., value evidence dossiers)

• Keep up to date with methodologies and guidelines (including those from regulatory authorities and reimbursement agencies) and communicate findings to cross-functional study teams as needed

Qualifications

Education:

• PhD in Health Services Research, Statistics, Psychometrics, Outcomes Research or closely related field with 5+ years of relevant work experience in the Clinical Outcome Assessment (COA) field OR Master's Degree in Health Services Research, Statistics, Psychometrics, Outcomes Research or closely related field with 7+ years of relevant work experience in the COA field OR Bachelor's Degree in Health Services Research, Statistics, Psychometrics, Outcomes Research or closely related field with 15+ years of relevant work experience in the COA field (including 10+ years in industry)

Required Experience and skills:

• Strong knowledge of methodological approaches and technical aspects (i.e. study design, data analysis and interpretation) related to COA development, validation, electronic migration and interpretation to support clinical trials and observational studies

• Experienced in COA/PRO requirements for regulatory and reimbursement agencies

• Able to drive COA-related quantitative analyses with cross-functional teams

• Able to develop strong internal relationships with cross-functional teams

• Able to understand, interact and responds to multiple internal and external customers

• A track record of COA-related scientific presentations and publications

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

BARDS2020

#eligibleforERP

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

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.

We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights

EEOC GINA Supplement

Pay Transparency Nondiscrimination

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas 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, generally Tuesday, Wednesday and either Monday or 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 Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education.

Expected US salary range:

Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here.

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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

*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.

Job Posting End Date:10/21/2024

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:R313228