Global Lead Biostatistician – Clinical Development

Quality Talent Group; New Providence (NJ); On-site; USD 140,000 - 200,000; Full time

Benefits offered by this job

Competitive benefits

Paid time off

Health insurance

Job summary

Quality Talent Group is seeking a Lead Biostatistician to steer biostatistics operations in our clinical development programs. You will apply advanced statistical methods and ensure regulatory-aligned analysis and reporting.

The role requires a PhD or MS in Statistics or related field with substantial experience in biostatistics, CDISC/ADaM, and SAS or R. Strong collaboration with cross-functional teams and external partners is essential for successful regulatory submissions.

Qualifications

• Graduate degree in Statistics or related quantitative field with 4+ years (PhD) or 6+ years (MS) industry experience.
• Strong background in clinical development biostatistics and regulatory processes.
• Proficiency in CDISC SDTM/ADaM datasets and FDA standards.
• Excellent communication and cross-functional collaboration skills.

Responsibilities

• Lead biostatistics operations for clinical development programs.
• Serve as Lead Statistical SME, applying appropriate methodologies.
• Oversee project-level statistical activities and vendor oversight.
• Collaborate with cross-functional and external partners for submissions.

Skills

Biostatistics expertise

Statistical methods

Cross-functional collaboration

SAS or R programming

Education

PhD in Statistics or related field

MS in Statistics or related field

Tools

SAS

R

Job description

Quality Talent Group is seeking a Lead Biostatistician to steer biostatistics operations in our clinical development programs. You will apply advanced statistical methods and ensure regulatory-aligned analysis and reporting.

The role requires a PhD or MS in Statistics or related field with substantial experience in biostatistics, CDISC/ADaM, and SAS or R. Strong collaboration with cross-functional teams and external partners is essential for successful regulatory submissions.