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Raleigh, NC 27617

Posted: 05/31/2023 Employment Type: Direct Hire/Perm Job Category: Data Sciences Job Number: 540438 Is job remote?: No Country: United States

Job Description

Your role:
  • As an active team member of the Statistical Consulting and Research team, perform consultancy tasks in a diverse range of projects involving study design, data analysis, modeling and inference, expert testimony, regulatory guidance
  • Serve as the face and main point of contact for clients in the design of clinical trials and other scientific projects requiring methodological input or requiring expert statistical support
  • Provide expertise in one or more of the following areas:
  • Experimental design
  • Bayesian methods
  • Adaptive design
  • Validation of diagnostic tests, devices, and/or biomarkers
  • Missing data, multiple imputation
  • Historical controls
  • Rare and orphan diseases
  • Regulatory pathways
  • Support internal operational teams in their implementation of studies and methods, including mentoring on complex protocols and area of expertise
  • Assess the developmental status of new projects and identify clients’ needs
  • Lead or contribute to efforts to publish (posters, presentations, manuscripts) in area of expertise and maintain active membership in key scientific societies (e.g., International Biometric Society, Society for Clinical Trials)
  • Write and review statistical sections of protocols, including performing sample size and power calculations addressing unique and challenging situations
  • Prepare reports summarizing consultancy findings, such as statistical modelling of endpoint selection and other study design features
  • Develop SAS or R programs to perform modelling and ad hoc analyses
  • Develop and maintain state-of-the-art knowledge on advanced statistical methods and standard practices in clinical trials
  • Review statistical and clinical reports, including NDA, IND, BLA, and other relevant submission package materials
  • Support clients in their preparation for meetings and other interactions with regulatory health authorities, such as the EMA and FDA
  • Participate in business development activities to support the successful conversion of prospects into clients, including assisting in the identification and assessment of new opportunities and writing technical/research strategy sections of proposals and applications
  • Serve as the voting member statistician on industry- and government-sponsored IDMCs for randomized clinical trials


Your profile:
  • Master’s degree or Doctorate (PhD, ScD, DrPH) in (Bio)Statistics, or Master’s degree or Doctorate in another quantitative science with substantial coursework in statistics
  • At least 5 years of experience in clinical biostatistics
  • Fluent English
  • Experience serving as a point of contact for clients
  • Excellent interpersonal skills (proven communication, organizational and time management, and flexibility)
  • Passionate about science and clinical research
  • Motivation and ability to build client partnerships
  • Knowledge of Good Clinical Practice and regulations governing clinical trials and electronic data
  • Trained in SAS and R programming
  • Experience using sample size and other statistical software (e.g., PASS, EAST)
  • Impeccable attention to detail
  • Ability to work independently
  • Team player
  • Problem solver
  • Flexible to travel
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