Lead Biostatistician – Clinical Statistics SME

Quality Talent Group; Summit (NJ); On-site; USD 150,000 - 190,000; Full time

Benefits offered by this job

Competitive benefits

Paid time off

Health insurance

Retirement plan

EAP program

Well-being reimbursement

Parental leave

Volunteer time

Learning & development

Job summary

Quality Talent Group in Summit, New Jersey is seeking a Lead Biostatistician to oversee biostatistics operations for diverse clinical development programs. You will serve as the Statistical SME, applying robust methodologies and ensuring compliance with regulations.

You will lead project-level statistics, oversee vendors, and partner with cross-functional teams and external collaborators to support publications and regulatory interactions.

Qualifications

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

Responsibilities

• Lead and manage biostatistics operations for clinical development programs.
• Serve as the Lead Statistical SME, applying appropriate statistical methodologies.
• Oversee statistical activities at the project level, including vendor oversight.
• Collaborate cross-functionally and with external partners to support project success.
• Provide statistical support for regulatory submissions and interactions with health authorities.

Skills

Biostatistics expertise

Cross-functional collaboration

Communication skills

Statistical analysis

Education

PhD in Statistics or related field

MS in Statistics or related field

Tools

SAS

R

CDISC SDTM/ADaM

Job description

Quality Talent Group in Summit, New Jersey is seeking a Lead Biostatistician to oversee biostatistics operations for diverse clinical development programs. You will serve as the Statistical SME, applying robust methodologies and ensuring compliance with regulations.

You will lead project-level statistics, oversee vendors, and partner with cross-functional teams and external collaborators to support publications and regulatory interactions.