Lead Biostatistician, Clinical Trials & Submissions

Quality Talent Group; Short Hills (NJ); On-site; USD 170,000 - 230,000; Full time

Job summary

Quality Talent Group in New Jersey seeks a Lead Biostatistician to drive biostatistics operations across clinical development programs. You will design, analyze, report, and interpret trial data, acting as the Lead Statistical SME to align with regulatory expectations.

The role requires a PhD or MS in statistics or related field with substantial clinical trial experience, CDISC SDTM/ADaM proficiency, and strong SAS or R skills.

Qualifications

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

Responsibilities

• Lead biostatistics operations for clinical development programs.
• Serve as Lead Statistical SME and ensure regulatory alignments.
• Oversee statistical activities at the project level and vendor oversight.
• Collaborate with cross-functional teams and external partners.
• Provide statistical support for regulatory submissions and interactions.

Skills

Statistical methods

Cross-functional collaboration

Regulatory submissions

CDISC/SDTM/ADaM

SAS/R programming

Education

Graduate degree in Statistics or related quantitative field

Tools

SAS

R

Job description

Quality Talent Group in New Jersey seeks a Lead Biostatistician to drive biostatistics operations across clinical development programs. You will design, analyze, report, and interpret trial data, acting as the Lead Statistical SME to align with regulatory expectations.

The role requires a PhD or MS in statistics or related field with substantial clinical trial experience, CDISC SDTM/ADaM proficiency, and strong SAS or R skills.