Global Biostatistics Lead - Clinical Development

Quality Talent Group; Chatham (NJ); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Health insurance

Paid time off

Retirement program

EAP and mental well-being resources

Global exercise/well-being reimburse.

Parental leave

Volunteer time

Learning and development opportunities

Job summary

Quality Talent Group is seeking a Senior Biostatistician/Lead for clinical development programs in the United States. You will oversee statistical design, analysis, and reporting of trials, and serve as SME for regulatory interactions.

Ideal candidates hold a PhD or MS in statistics, are proficient in SAS or R, and have CDISC SDTM/ADaM experience, with strong communication across teams and external partners.

Qualifications

• PhD in statistics or related field; 4+ years industry with PhD, or 6+ years with MS.
• Strong clinical development biostatistics background and regulatory processes.
• Proficiency in SAS or R programming.
• Excellent communication and cross-functional collaboration skills.
• Advanced knowledge of CDISC standards (SDTM/ADaM).

Responsibilities

• Lead biostatistics operations for clinical programs with high-quality analyses.
• Serve as Lead Statistical SME and ensure regulatory alignment.
• Oversee project-level statistics activities including vendor oversight.
• Collaborate with external partners for publications and manuscripts.
• Provide statistical support for regulatory submissions.

Skills

SAS

R programming

CDISC/SDTM/ADaM

Biostatistics leadership

Cross-functional collaboration

Education

PhD in Statistics

MS in Statistics

Job description

Quality Talent Group is seeking a Senior Biostatistician/Lead for clinical development programs in the United States. You will oversee statistical design, analysis, and reporting of trials, and serve as SME for regulatory interactions.

Ideal candidates hold a PhD or MS in statistics, are proficient in SAS or R, and have CDISC SDTM/ADaM experience, with strong communication across teams and external partners.