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Real World Evidence (RWE) Analyst

TekWissen LLC

Santa Monica, CA(remote)

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JOB DETAILS
SALARY
$75–$84
SKILLS
Analysis Skills, Best Practices, Biology, Biometrics, Biostatistics, Biotech and Pharmaceutical, Communication Skills, Contract Research Organization (CRO), Cross-Functional, Data Analysis, Data Collection, Diversity, Drug Development, Electronic Publishing, Epidemiology, HIV/AIDS (Acquired Immune Deficiency Syndrome), Health Economics, Hepatitis B, Hepatitis C, Marketing, Medical Record System, Oncology, Performance Metrics, Pharmacovigilance, Presentation/Verbal Skills, Protocol Analysis, R Programming Language, Regulations, Reporting Dashboards, Reporting Skills, Research & Development (R&D), Research Protocols, Statistical Analysis System (SAS), Statistical Programming Languages, Statistics, Team Player, Time Management, Workforce Management, Writing Skills
LOCATION
Santa Monica, CA
POSTED
5 days ago
Overview:
TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients world-wide. The below job opportunity is with one of our Biotech clients who researches develop and commercializes drugs. The company focuses primarily on antiviral drugs used in the treatment of HIV, hepatitis B, hepatitis C, and influenza, including Harvoni and Sovaldi.

Position: Real World Evidence (RWE) Analyst
Location: Remote
Duration: 6 Months
Job Type: Temporary Assignment
Work Type: Remote
Role Summary
  • The RWE Analyst will contribute to the client Real-World Evidence/Health Economic Outcomes Research (RWE/HEOR) Team as part of an effort to contribute to the strategies of the broader client Evidence Generation Team, which will include the conduct of timely, relevant, and rigorous analysis of real-world data (RWD) to address critical research questions and contribute to cross-functional initiatives.
  • The RWE Analyst will be responsible for developing, reviewing, and providing feedback on study documents, such as protocols and statistical analysis plans, and executing planned data analyses using administrative claims, electronic health record (EHR), and observational registry databases. The RWE Analyst will work closely with project teams to manage timelines and workflows, and to communicate results and updates to internal cross-functional stakeholders, including people from client Biometrics, client Clinical Operations, and client Safety.
  • The RWE Analyst will have access to real-world databases licensed across Client and client and act as stewards of Client's and client's best research practices, standards, and methodologies underlying the use of RWE.
Key Responsibilities:
  • Support development of and provide critical appraisal of study protocols for research projects using RWD (e.g., medical claims, EHR, and observational registry databases)
  • Lead or support development of statistical analysis plans in collaboration with internal stakeholders (e.g., client Biometrics and programming team members)
  • Conduct data reviews for primary/secondary data collected to ensure quality and reliability
  • Communicate study results with a broader internal cross-functional audience
  • Adapt performance metrics and dashboards for RWE projects
  • Support preparation of reports and/or publication materials (e.g., abstracts, manuscripts)
  • Support cross-functional initiatives to develop and refine internal procedures, workflows, and best practices
Basic Qualifications
  • Master's degree in Epidemiology, Biostatistics, Statistics or related discipline from an accredited institution and 4+ years of experience working with a broad range of RWD, in academia, at a contract research organization, or in the biopharmaceutical industry OR
  • Bachelor's degree in Epidemiology, Biostatistics, Statistics or related discipline from an accredited institution and 6+ years of experience working with a broad range of RWD, in academia, at a contract research organization, or in the biopharmaceutical industry
Preferred Qualifications:
  • Master's degree or Doctoral level training in Epidemiology, Biostatistics, Statistics or related discipline from an accredited institution
  • 4+ years of oncology research experience highly preferred
  • In-depth knowledge of claims-based RWD (e.g., HealthVerity, Optum) and prior experience of using claims-based RWD in oncology research
  • Experience working with EHRs (e.g., IQVIA, Flatiron) and registry databases
  • Prior experience of using RWD for RWE in regulatory applications, post-marketing studies, and pharmacovigilance
  • Experience with external control arm (ECA) methodologies
  • In-depth understanding of the principles of epidemiologic research methods and statistical concepts in support of the analyses and demonstrated proficiency in statistical analysis programming languages commonly used in life sciences (e.g., SAS, R)
  • Experience in biopharmaceutical industry
  • Excellent verbal, written and presentation skills, including the ability to effectively communicate statistical methodology and analysis results
  • Ability to work independently and collaboratively in a constantly changing, diverse, and matrix environment
TekWissen Group is an equal opportunity employer supporting workforce diversity.

About the Company

T

TekWissen LLC

WE THE TEKWISSEN PEOPLE

TekWissen offers you a broader portfolio of services, industry-leading solutions, and the meaningful innovations that give you greater flexibility and speed to respond to market dynamics, reduced costs and risk to improve enterprise performance, and increased productivity to enable growth.

To keep pace with global market demands, TekWissen keeps its finger on the pulse of change. Our organized approach to guiding a project from its inception to closure. Managing projects is becoming more and more important as we enter the digital era. To cope with the pace that this transition demands, a method is required to manage projects so they can yield quality work, while incorporating efficient use of time and resources.

Project involves identifying which quality standards are relevant to the project and determining how to satisfy them.

It is important to perform quality planning during the Planning Process and should be done alongside the other project planning processes because changes in the quality will likely require changes in the other planning processes, or the desired product quality may require a detailed risk analysis of an identified problem. It is important to remember that quality should be planned, designed, then built in, not added on after the fact.

Capabilities and accomplishments in one TekWissen business enhance the opportunity for success in the others. Put simply, TekWissen's unique combination of attributes promotes success.



COMPANY SIZE
100 to 499 employees
INDUSTRY
Computer/IT Services
FOUNDED
2009
WEBSITE
http://www.tekwissen.com/