Principal Biostatistician/Senior Principal Biostatistician

This is a fully remote position, open to applicants in Canada.

📋 Description

• Offers statistical leadership and guidance throughout all stages of clinical development.

• Key responsibilities involve advising clients on clinical trial study design and regulatory strategies.

• Composing and evaluating statistical methods and sample size sections within protocols.

• Drafting and assessing statistical analysis plans for intricate study designs.

• Analyzing statistical outcomes and delivering presentations on the results.

• Directing complex programs such as NDA/BLA/MAA submissions or intricate, multi-protocol initiatives while providing statistical oversight.

• Act as a subject matter expert in one or more domains (e.g., Bayesian adaptive study design, survival analysis, DMC, submissions).

⛳️ Requirements

• For Senior Principal Biostatistician: Master's degree or equivalent in Statistics, Biostatistics, or a related field with over 12 years of experience; or a PhD in Statistics, Biostatistics, or a related field with 9+ years of experience.

• For Principal Biostatistician: Master's degree or equivalent in Statistics, Biostatistics, or a related field with 10+ years of experience; or a PhD in Statistics, Biostatistics, or a related field with 7+ years of experience.

• Extensive experience with regulatory submissions.

• Significant experience in consulting with clients on clinical trial study design and regulatory strategy.

• Deep understanding of statistical methodologies (e.g., Bayesian adaptive study design, survival analysis, repeated measures).

• Strong knowledge of industry standards such as ICH guidelines, CDISC data structures, 21 CFR Part 11, and FDA guidelines.

• Proficient in SAS.

🏝️ Benefits

• Discretionary annual bonus.

• Health insurance.

• Retirement savings benefits.

• Life insurance.

• Disability benefits.

• Parental leave.

• Paid time off for sick leave and vacation.