Principal COA/PRO Researcher

Senior/Principal Quantitative COA/PRO Researcher – Evidera (UK/EU/CA)

Evidera is a business unit of Pharmaceutical Product Development, LLC (PPD) a leading global contract research organization (CRO), a preeminent provider of evidence-based solutions and part of Thermo Fisher Scientific.

We provide integrated scientific expertise and global operational capabilities to help clients generate the evidence needed to optimize the market access and commercial potential of products.

Location/Division Specific Information

This is a great time to join our rapidly growing global COA team! We are looking to fill this level role in Canada, UK or EU. This role is flexible to office/flex/fully remote work arrangements.

Our COA team, specializing in quantitative analysis of COA/patient-reported outcomes (PRO) endpoints for clinical studies and assessment of measurement properties of COA/PRO tools, has been extremely successful in the past few years and is actively growing. We are looking for an enthusiastic colleague at senior level who can contribute to our continued success and growth.

Discover Impactful Work:

We are looking for a highly experienced senior researcher, with very strong statistical expertise, to apply their knowledge in leading projects in quantitative analysis of COA/PRO data from clinical studies to support pharmaceutical product review by regulatory and/or health technology assessment (HTA) agencies. We have built strong relationships and developed an outstanding reputation with a core group of bio-pharmaceutical clients for our ability to help them shape and execute the statistical analyses of COA/PRO data to ensure successful regulatory and reimbursement submissions. Working as a true thought partner with clients, you will help them shape and define the research before even receiving an RFP! The successful candidate will be part of multi-disciplinary research teams to provide statistical expertise and methodological leadership at all stages of projects from planning to dissemination.

A day in the Life:

• Successfully leading a team to complete all aspects of COA/PRO analytic projects.
• Contributing to the preparation of study plans, reviewing study materials, developing statistical analysis plans, working with data analysts to execute analyses, and assist with the interpretation and dissemination of finings.
• Leading meetings with clients around statistical and scientific methods and to present results from analyses.
• Providing scientific strategy advice to clients related to scientific and statistical issues.
• Leading proposal development and other business development activities as required. 
• Serving as the scientific and statistical thought leader internally and externally.
• Maintaining expertise in state-of-the-art data manipulations and statistical analyses.
• Mentoring junior statisticians, research associates, and/or data analysts, and overseeing their work in the context of projects.

Education

• PhD in (Statistics, Biostatistics, Health Outcomes/Services Research, or Epidemiology) and more than 5 years’ experience in relevant field; or
• Master’s degree in scientific discipline (Biostatistics, Statistics, Health Outcomes/Services Research or Epidemiology) and more than 8 years’ experience in relevant field

Experience

• Extensive practical experience in the application of statistics in clinical study design and outcomes research
• Strong basis in fundamental statistical concepts and methods and familiarity with techniques such as but not limited to ANCOVA, MMRM, survival analysis (continuous and discrete), ROC analysis, logistic regression (binary, multinomial and conditional), multiple imputation of longitudinal data, propensity score (IPW, stratification, matching), sample size calculation, COA/PRO instrument assessment and validation (psychometric analysis).

Knowledge, Skills, Abilities

• Conversant knowledge of FDA and other regulatory guidances and regulations
• Deep and demonstrated understanding of clinical trial study datasets (e.g., SDTM and ADaM) to meet regulatory requirements and expectations (e.g., CDISC standards)
• Advanced understanding of COA/PRO measures and instruments  Excellent understanding of SAS®, clinical biostatistics, and ICH guidances/estimand framework
• SAS, R, Microsoft Office Suite of programmes (other languages are considered a benefit)  

Physical Requirements / Work Environment

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

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