Lead Biostatistician for Clinical Trials & Submissions

Quality Talent Group; Springfield (NJ); On-site; USD 140,000 - 190,000; Full time

Benefits offered by this job

Competitive benefits package

Paid time off

Health insurance benefits

Retirement program

Employee Assistance Program (EAP) and…

Global exercise/well-being reimburs…

Adoption, fertility, and surrogacy…

Global parental leave

Paid company holidays and volunteer…

Learning and development opportunities

Job summary

Quality Talent Group in New Jersey is seeking a Lead Biostatistician to oversee biostatistics operations for clinical development programs, ensuring high-quality design, analysis, reporting, and interpretation of trial data.

The role requires a PhD or MS with substantial experience in clinical development biostatistics, proficiency in SAS or R, and knowledge of CDISC/FDA SDTM/ADaM standards; you will collaborate with vendors and health authorities.

Qualifications

• PhD in Statistics or related field with 4+ years industry experience or MS with 6+ years
• Strong background in clinical development biostatistics, statistical methods, and industry processes
• Proficiency in SAS or R programming
• Excellent communication, collaboration, and cross-functional teamwork skills
• Advanced knowledge of CDISC standards for SDTM and ADaM datasets

Responsibilities

• Lead biostatistics operations for clinical development programs, ensuring high-quality design, analysis, reporting, and interpretation of trial data
• Serve as Lead Statistical SME, applying appropriate methodologies per procedures and regulatory expectations
• Oversee statistical activities at project level, including vendor oversight and compliance with standards
• Collaborate with cross-functional teams and external partners to support project success and manuscript development
• Provide statistical support for regulatory submissions and interactions with health authorities

Skills

SAS

R

CDISC

Statistics

Education

PhD in Statistics or related field

MS in Statistics or related field

Job description

Quality Talent Group in New Jersey is seeking a Lead Biostatistician to oversee biostatistics operations for clinical development programs, ensuring high-quality design, analysis, reporting, and interpretation of trial data.

The role requires a PhD or MS with substantial experience in clinical development biostatistics, proficiency in SAS or R, and knowledge of CDISC/FDA SDTM/ADaM standards; you will collaborate with vendors and health authorities.