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

Primary Talent Partners has a new contract opening for a Senior Scientist, Patient-Centered Endpoints & Strategy (PaCES) to join our pharmaceutical client in Rahway, NJ. This is a 19-month contract to start with the potential for extensions. 


Pay: $46.00 - $56.00/hr; W2 contract, no PTO, no Benefits. ACA-compliant supplemental package available for enrollment. Candidates must be legally authorized to work in the United States and must be able to sit on Primary Talent Partners W2 without sponsorship.


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
• Supporting the PaCES lead to providing guidance on implementing COA/PRO instruments into studies by following Client standard processes
•  Attending 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 coordinating 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
  
  

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.
  

Software:

• MS office suite
  

Personality:

• Excellent communications skills.
• Take initiatives to understand the role.
• Curious about what we do.
• Eager to understand more about this role.
• Adapts well within the group.
  
  

Note:

• Hybrid role. 3 days/week onsite. Days option between Monday-Thursday.
• Work Location- 2 options: West Point, PA and Rahway, NJ.
• HD can apply as well.
• Please submit original copy of resume(without contact details). Do mention the preferred work location and candidate's availability on the resumes.
• Please submit publications or add publication links on the resumes.
• Do not add skill table or recuiter's summary.
  
  
  

Primary Talent Partners is an Equal Opportunity / Affirmative Action employer committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, age, national origin, disability, protected veteran status, gender identity, or any other factor protected by applicable federal, state, or local laws.

If you are a person with a disability needing assistance with the application or at any point in the hiring process, please contact us at info@primarytalentpartners.com

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