Analytical Scientist

Analytical Scientist
  • $1 - $45.39 per Hour
    HOUR
  • Temporary
  • Durham NC, US Durham DURHAM US 27709
Job Ref: JO000125500
Sector: Science
Sub-sector: Food & FMCG
Date Added: 12 November 2021


Analytical Scientist

• Under direction of PRO manager, coordinate and lead the development of literature review to inform the COA strategy, identifiying the potential concepts of interest and the COA tools applicable to measure those.
• Under direction of PRO manager, coordinate and lead the development of COA/PRO specific studies to generate evidence of the fit-for-purpose of the tools implemented in the COA/PRO strategy.
• Support the appropiate implementation of PROs in clinical trials, including writing relevant portions of the clinical trial protocols, training investigative site personnel on PRO principles and appropriate administration of PROs in the clinical trials
• Collaborate with clinical and statistical teams to ensure that COAs are appropriate analyzed and described in statistical analysis plans, study reports and publications
• Under direction of PRO Manager, support relevant sections of documentation and communication and questions for regulatory agency meetings, support in meetings with regulatory agencies.
• Prepare abstracts and manuscripts presenting PRO results from clinical and PRO development and validation studies, aligned with publication strategy With PRO team, develop and provide training on COA-related topics to other departments, as needed

Experience, Knowledge & Soft Skill Requirements
• Experience in pharmaceuticals, particularly in drug development.
o To understand drug development process and the role that PRO/COAs play within it.
• Experienced with PRO/COA requirements for regulatory and HTA/reimbursement agencies including understanding of the FDA Patient Reported Outcomes Guidance
o To implement PRO/COA strategies for assets in development, assuring alignment with regulatory and reimbursement guidelines.
• Experience with managing PRO development and validation projects
o To 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
Basic qualifications:
• Bachelor’s degree in Psychology, Psychometrics, Social Sciences, Outcomes Research, Health Outcomes research or a closely related discipline
• Experience with managing PRO development and validation projects
Preferred qualifications:
• Master’s degree Psychology, Psychometrics, Social Sciences, Outcomes Research, Health services research or a closely related discipline
• Experience in pharmaceuticals, particularly in drug development, so as to understand drug development process, with demonstrated experience in clinical trial planning and execution
• Experienced with PRO/COA requirements for regulatory and HTA/reimbursement agencies including understanding of the FDA Patient Reported Outcomes Guidance
• Strong communication skills, with stakeholder engagement with Clinical, Health outcomes and Regulatory
• ICT Skills (software, operating systems, hardware, etc.)
• Word, Powerpoint, Excel

SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.

SRGTalent
24/03/2022 12:00:00
USD 1.00 45.39 Hour
Contact Consultant:
Zachary Bodziak

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