Epidemiologist

  • Contract
  • Remote

SimulStat

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Remote, 12-month contract with potential to extend
 
The Epidemiologist will prepare statistical analysis plans and study protocols in support of the company’s Global Value & Access area with guidance and mentoring on new and complex issues. As an embedded member of the HEOR Analytics group, the Epidemiologist reports directly to the Head of HEOR Analytics. The incumbent will design and conduct statistical analyses of RWE from clinical trials and real-world data sources to assess the value of therapies. Additionally, the incumbent will interpret and communicate RWE results to internal stakeholders in GV&A.
 
Key Duties and Responsibilities:
 

  • Determine observational study design criteria – including source data, analytical methods, and analysis plans.
  • Write and prepare observational study analysis specifications, including statistical analysis plans (SAPs)
  • Designs, develops, and executes the technical/statistical infrastructure for the conduct and evaluation of clinical trials, observational studies, or real-world data (RWD) investigations.
  • Generate Evidence Plan for a new molecule and/or disease area with cross-functional drug development teams.
  • Assess RWD and clinical trial datasets for new molecule and/or disease area.
  • Support launch planning using RWE/RWD
  • Perform feasibility analysis for studies.
  • Plan observational studies and draft protocol synopsis (or protocol concept sheet)
  • Conduct observational studies, both primary data collection and secondary data use studies
  • Review analysis outputs for quality, including study analysis, ad hoc analysis, analysis to support conference or publications.
  • Collaborates with statistical programming and other functions to ensure timely delivery of TFLs with good quality. Provides input into programming specifications and review.
  • Develops statistical section of protocols, including sample size estimates and randomization plan.
  • Contributes to clinical study reports (CSRs) and related processes.
  • May author or co-author methodological or study-related publications and posters.
  • Implements design and analysis methods at the study level and participates in review discussions of studies assigned to others.

 
Knowledge, Skills and Experience:
 

  • Minimum master’s degree (e.g. MA, MSc, MPH) in Biostatistics, Statistics, Epidemiology, or Public Health related discipline, such as Outcomes Research from an accredited institution, with a minimum of five (5) years of relevant, post-graduation experience in pharma/biotech.
  • Strong track record of analysis of real-world data (RWD), including claims and EHR.
  • Formal training in Programming and demonstrated proficiency in statistical analysis programs commonly used in life sciences (SAS or R).
  • Understanding of epidemiology, outcomes research, policy research, and the application of retrospective or prospective studies to generate value evidence.
  • Knowledge of US secondary data sources required; additional experience with international data sources is preferred.
  • Experience in observational research study design, execution and communication.

 

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