Associate Principal Scientist Outcomes Research

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Job DescriptionUnder the general direction of the Patient-Centered Endpoints & Strategy (PaCES) group lead, the Associate Principal 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 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 Associate 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:nnCoordinate global COA/PRO strategic plans in support of Early Development Teams (EDTs), Value Evidence Sub-teams (VESTs) and Clinical Sub-teams (CST) to assure alignment with product franchise goalsnProvide assistance on the selection and/or development of COA/PRO instruments for inclusion in studiesnProvide guidance on implementing COA/PRO instruments into studies by following company standard processesnFacilitate alignment of the selection of an appropriate endpoint measure to satisfy both regulatory and reimbursement needsnCoordinate COA/PRO related sections of evidence packages to be submitted to regulatory and reimbursement agenciesnCoordinate the development, validation, implementation, and utilization of instruments aimed at measuring COA/PROs in the context of clinical trials and/or observational studiesnSupport literature searches to support COA/PRO endpoint strategiesnSupport/Produce scientific communications (abstracts, poster presentations, podium presentations, manuscripts, etc.)nKeep up to date with COA/PRO methodologies and guidelines (including those from regulatory authorities and reimbursement agencies) and communicate findings to cross-functional study teams as needed.nnQualificationsEducation:nnPhD in Health Services Research, Statistics, Psychometrics, Outcomes Research or closely related field with 3 years of relevant work experience in the COA field OR Master's Degree in Health Services Research, Statistics, Psychometrics, Outcomes Research or closely related field with 5 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 7 years of relevant work experience in the COA fieldnnRequired Experience:nnFamiliar with COA/PRO requirements for regulatory and reimbursement agenciesnKnowledge of methodological approaches and technical aspects (study design, data analysis and interpretation) of COA/PRO development, validation, electronic migration and interpretation into clinical trial and observational studiesnAbility to understand and respond to multiple internal and external customersnStrong project management and communication skillsnExperience with COA/PRO-related scientific presentations and publicationsnnWe are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we follow the science that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe. Who we are ... We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.What we look for ... Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us-and start making your impact today.NOTICE FOR INTERNAL APPLICANTSIn 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.Residents of ColoradoClick here to request this role's pay range.BARDS2020#eligibleforERPEmployees 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 HERECurrent Contingent Workers apply HEREUS 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.For more information about personal rights under Equal Employment Opportunity, visit:EEOC Know Your RightsEEOC GINA Supplement Pay Transparency NondiscriminationWe 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. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.Under New York City, Washington State and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. 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 salary range: $130,960.00 - $206,200.00Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here.Learn more about your rights, including under California, Colorado and other US State ActsSearch 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: RegularRelocation:DomesticVISA Sponsorship:YesTravel Requirements:10%Flexible Work Arrangements:HybridShift:Valid Driving License:Hazardous Material(s):Requisition ID:R225309n,occupationalCategory:Principal Scientist,baseSalary:{@type:MonetaryAmount,currency:USD,value:{@type:QuantitativeValue,minValue:,maxValue:,unitText:}}}

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