Senior Biostatistician - Clinical Program Leadership

Precision For Medicine; Peapack-Gladstone (NJ); On-site; USD 147,300 - 243,000; Full time

Benefits offered by this job

Discretionary annual bonus

Health insurance

Retirement plan

Life insurance

Disability benefits

Parental leave

Paid time off

Job summary

Precision Medicine Group seeks an experienced Biostatistician to provide statistical leadership across all phases of clinical development. You will consult with sponsors on study design and regulatory strategy, develop statistical methods, author SAPs, and oversee complex NDA/BLA submissions.

You will mentor statisticians and collaborate with sponsors, CROs and DMCs. The role requires advanced degrees in statistics with extensive experience and expertise in Bayesian adaptive design, survival

Qualifications

• Master's degree or PhD in Statistics/Biostatistics or related field with 12+ years of experience (12+ for MS, 9+ for PhD).
• Principal level requires Master's with 10+ years or PhD with 7+ years of experience.

Responsibilities

• Consult with clients regarding clinical trial design and regulatory strategy.
• Develop and review statistical methods for protocols.
• Provide sample size calculations and analyze complex study designs.
• Author and review SAPs for complex trials and multi-protocol programs.
• Mentor and train other statisticians and liaise with sponsors and vendors.
• Lead statistical oversight for NDA/BLA/MAA submissions and DMC reporting.

Skills

Statistical leadership

Client consultation

SAS

Regulatory strategy

Biostatistics expertise

Bayesian adaptive design

Survival analysis

DMC experience

Presentation skills

Mentoring

Education

PhD in Statistics/Biostatistics

MS in Statistics/Biostatistics

Tools

SAS

Job description

Precision Medicine Group seeks an experienced Biostatistician to provide statistical leadership across all phases of clinical development. You will consult with sponsors on study design and regulatory strategy, develop statistical methods, author SAPs, and oversee complex NDA/BLA submissions.

You will mentor statisticians and collaborate with sponsors, CROs and DMCs. The role requires advanced degrees in statistics with extensive experience and expertise in Bayesian adaptive design, survival