Principal Biostatistician/Senior Principal Biostatistician

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

📋 Description

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

• Advising clients on clinical trial study design and regulatory strategies.

• Composing and evaluating statistical methods and sample size sections of study protocols.

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

• Reviewing statistical analyses and presenting the findings effectively.

• Overseeing complex programs, including NDA/BLA/MAA submissions or intricate multi-protocol initiatives.

• Providing comprehensive statistical oversight.

• Acting as a subject matter expert in areas such as Bayesian adaptive study design, survival analysis, DMC, and submissions.

• Mentoring and training fellow statisticians.

⛳️ Requirements

• 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 over 9 years of experience.

• Master's degree or equivalent in Statistics, Biostatistics, or a related field with at least 10 years of experience; or a PhD in Statistics, Biostatistics, or a related field with a minimum of 7 years of experience.

• Extensive experience with regulatory submissions.

• Significant experience advising clients on clinical trial study design and regulatory strategies.

• 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 regulations.

• Proficiency in SAS.

🏝️ Benefits

• Health insurance.

• Retirement savings benefits.

• Life insurance.

• Disability benefits.

• Parental leave.

• Paid time off for sick leave and vacation.

• Discretionary annual bonus.