Lead Biostatistician & Statistical SME Clinical Development

Quality Talent Group; Chatham (NJ); On-site; USD 150,000 - 210,000; Full time

Benefits offered by this job

Excellent health benefits

Paid time off

Retirement plan

EAP & well-being resources

Learning and development opportunities

Job summary

Quality Talent Group is seeking a senior Biostatistician Lead to oversee biostatistics operations in our global clinical development programs. You will act as the Lead Statistical SME, guiding the design, analysis, and interpretation of trial data in collaboration with cross-functional teams.

The role requires a PhD in Statistics or a related field (or a MS with substantial experience), strong proficiency in SAS or R, and deep familiarity with CDISC standards for SDTM/ADaM datasets.

Qualifications

• Graduate degree in Statistics or related quantitative field; typically 4+ years with PhD or 6+ years with MS.
• Strong background in clinical development biostatistics and regulatory standards.
• Proficiency in SAS or R programming.
• Excellent communication and cross-functional collaboration skills.
• Advanced knowledge of CDISC and FDA SDTM/ADaM standards.

Responsibilities

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

Skills

Biostatistics

SAS

R

CDISC standards

Regulatory submissions

Cross-functional teamwork

Communication

Education

PhD in Statistics or related field

MS in Statistics (6+ years experience)

Tools

SAS

R

Job description

Quality Talent Group is seeking a senior Biostatistician Lead to oversee biostatistics operations in our global clinical development programs. You will act as the Lead Statistical SME, guiding the design, analysis, and interpretation of trial data in collaboration with cross-functional teams.

The role requires a PhD in Statistics or a related field (or a MS with substantial experience), strong proficiency in SAS or R, and deep familiarity with CDISC standards for SDTM/ADaM datasets.