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
- 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
- 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.