Principal Coa/pro Researcher

1 month ago

London, United Kingdom Thermo Fisher Scientific Full time

Our team of colleagues in clinical research services are at the forefront of getting cures to market. We bring a high caliber of scientific and clinical expertise to the development of drugs that address the world’s most challenging health concerns. Our Clinical Research team, who powers our PPD® clinical research portfolio, are part of our leading global contract research organization (CRO).

**SENIOR/PRINCIPAL QUANTITATIVE COA/PRO RESEARCHER**

**We are looking to fill this role in the US, Canada, UK or EU and we are flexible to fully remote work**

**_
Evidera is one of the preeminent commercial entities analyzing effectiveness, establishing evidence, and substantiating value of health treatments within the global health industry. Through its market leading portfolio of health economics, outcomes research, market access, data analytics and epidemiology services, it partners with life sciences organizations worldwide to optimize the market access and commercial success of their products. Our research and consulting services are driven by world-class science and thought leadership and leverage a unique combination of capabilities. 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._**

**Position Overview**:
**Essential Duties and Responsibilities (other duties may be assigned)**:
Responsibilities include:

- 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, Professional Skills & Experience**:

- 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).
- Excellent understanding of SAS®, clinical biostatistics, and ICH guidances/estimand framework
- 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
- 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
- SAS, R, Microsoft Office Suite of programmes (other languages are considered a benefit)

**Personal Skills & Competencies**:

- Ability to communicate effectively, in non-technical terms, with project team members.
- Ability to direct large portfolio of projects in terms of dollar volume and number of projects.
- Able to respond to clients’ request promptly
- Excellent written and oral communication skills: scientific, professional, and consulting.
- Ability to develop positive, collegial, and productive relationships with colleagues and clients.
- Excellent time management and logistic skills to be highly effective in fast-paced, deadline-driven work environment.

**About Evidera**:
Evidera is a business unit within Pharmaceutical Product Development, LLC (PPD) a leading global contract research organization (CRO), and a is a preeminent provider of evidence-based solutions. Our integrated scientific expertise, global operational capabilities and commercial experience helps clients generate the evidence needed to optimize market access and increase the commercial potential of their products.

**Perks**:

- We offer a competitive salary and benefits package, with clear opportunities for growt

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