Senior Biostatistician — NDA/BLA Submissions Lead

Pfm; Canada; On-site; CAD 149,000 - 246,000; Full time

Benefits offered by this job

Discretionary annual bonus

Health insurance

Retirement savings benefits

Life insurance and disability benefits

Parental leave

Paid time off (sick leave & vacation)

Other benefits

Job summary

Precision Medicine Group in Canada seeks a Senior Principal Biostatistician to lead statistical leadership across clinical development, NDA/BLA/MAA submissions, and regulatory strategy. You will consult with sponsors, develop study design, write SAPs, review analyses, and provide SME oversight.

The role requires 12+ years (or 9+ with PhD) in statistics, strong experience with regulatory submissions, Bayesian adaptive designs, survival analysis, DMCs, and SAS.

Qualifications

• Senior Principal Biostatistician level: 12+ years (MS) or 9+ years (PhD) in Statistics/related field.
• Principal Biostatistician level: 10+ years (MS) or 7+ years (PhD) in Statistics/related field.
• Strong experience with regulatory submissions and clinical trial design.

Responsibilities

• Consult with clients regarding clinical trial study design and regulatory strategy.
• Develop and review statistical methods for protocols and SAPs.
• Provide and verify sample size calculations.
• Lead complex NDA/BLA/MAA submissions and multi-protocol programs.
• Review statistical outputs and sections of reports; mentor other statisticians.

Skills

Bayesian adaptive study design

Survival analysis

Repeated measures

Regulatory submissions

Client consulting

Biostatistics leadership

DMCs participation

Education

Master's or PhD in Statistics/Biostatistics

Tools

SAS

Job description

Precision Medicine Group in Canada seeks a Senior Principal Biostatistician to lead statistical leadership across clinical development, NDA/BLA/MAA submissions, and regulatory strategy. You will consult with sponsors, develop study design, write SAPs, review analyses, and provide SME oversight.

The role requires 12+ years (or 9+ with PhD) in statistics, strong experience with regulatory submissions, Bayesian adaptive designs, survival analysis, DMCs, and SAS.