You will have the opportunity to be client facing and will be responsible for the design, development, execution and interpretation of clinical trial analysis for early phase clinical projects

Main responsibilities:

  • Lead the Biostatistics portion of clinical studies; collaborating with the Lead Statistical Programmer and project team.
  • Act as the client liaison for the Biostatistics portion of the project team.
  • Mentor peer and/or junior Biostatisticians
  • Collaborate with team members to develop Biostatistics training program and participate in providing training.
  • Interacts with other departments (data management, clinical, scientific affairs, etc.) about statistical assessment of procedures and methods;
  • Develop statistical analysis plans;
  • Collaborate and support the Statistical Programmers to review and QC the TFLs to ensure quality client deliveries.
  • Participate in the development of SAS programs and macros utilities pertaining to clinical trials;
  • Develop and program PK statistical analysis
  • Participate in the development of CDISC deliverables (SDTM, ADaM, and Define-XML);
  • Participate in the development of tables of summary statistics and graphics for clinical aspects of clinical trials;
  • Develop randomization and sample size programs for clinical studies.
  • Provide statistical input for protocol and CRF development
  • Act as biostatistics support for Medical Writing team

Desired profile:

  • B.Sc. or M.Sc. in statistics or equivalent is required with 4 or more years of experience;
  • Good working knowledge of SAS and related programming experience
  • Experience in CRO and/or pharmaceutical fields developing Statistical Analysis Plans and Tables, Figures and Listings for client deliverables.
  • Ability to work independently as well as in the team environment.
  • Leadership ability with history of successfully delivering complex projects within timelines and expected quality.
  • Good knowledge of statistical principles and concepts;
  • Demonstrated expertise in technical, and statistics terminology;
  • Works on fairly complex problems in which analysis of situations or data requires an evaluation of intangible variables;
  • Must have solid understanding of therapeutic indications and study hypothesis;

Remote position can be based in either Canada or the US.

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