Senior Biostatistics Lead - Clinical Development & Submissions

Precision For Medicine; Peapack-Gladstone (NJ); On-site; USD 147,000 - 243,000; Full time

Benefits offered by this job

Discretionary annual bonus

Health insurance

Retirement savings benefits

Life insurance

Disability benefits

Parental leave

Paid time off (sick leave & vacation)

Job summary

Precision Medicine Group seeks a Senior Principal Biostatistician to lead statistical oversight across all phases of clinical development, including NDA/BLA/MAA submissions and multi-protocol programs.

You will consult with clients on study design, write and review statistical analysis plans, review analyses for accuracy, and mentor junior statisticians. Expertise in Bayesian methods, survival analysis, and regulatory standards is essential.

Qualifications

• Minimum Required: Senior Principal Biostatistician level with 12+ years (Master's) or 9+ years (PhD).
• Principal Biostatistician level: 10+ years (Master's) or 7+ years (PhD).
• Broad experience with regulatory submissions.
• Extensive experience consulting with clients on trial design and regulatory strategy.
• Superior understanding of statistical methodologies (e.g., Bayesian adaptive design, Survival analysis).
• Knowledge of ICH, CDISC, 21 CFR Part 11, FDA guidelines.
• Experience with SAS.

Responsibilities

• Consult with clients regarding clinical trial study design and regulatory strategy.
• Develop and review statistical methods for study protocols.
• Provide and verify sample size calculations.
• Author statistical analysis plans for complex study designs.
• Review statistical analyses and outputs for accuracy.
• Review sections of clinical study reports.
• Generate/randomization schedules.
• Provide statistical analyses to DMCs as unblinded biostatistician.
• Mentor and train other statisticians.
• Attend bid defense meetings for complex programs.

Skills

Regulatory submissions

Client consulting

Communication skills

Problem solving

Presentation skills

Organization & time management

Statistical expertise

Education

Master's degree or equivalent in Statistics/Biostatistics

PhD in Statistics/Biostatistics

Master's degree or equivalent in Statistics/Biostatistics (Senior Principal path)

PhD in Statistics/Biostatistics (Senior Principal path)

Tools

SAS

Job description

Precision Medicine Group seeks a Senior Principal Biostatistician to lead statistical oversight across all phases of clinical development, including NDA/BLA/MAA submissions and multi-protocol programs.

You will consult with clients on study design, write and review statistical analysis plans, review analyses for accuracy, and mentor junior statisticians. Expertise in Bayesian methods, survival analysis, and regulatory standards is essential.