Lead Biostatistician - Clinical Development & Submissions

Quality Talent Group; Mountainside (NJ); On-site; USD 140,000 - 190,000; Full time

Benefits offered by this job

Health insurance

PTO

Retirement plan

EAP & wellbeing

Job summary

Quality Talent Group is seeking a Lead Biostatistician to oversee biostatistics operations within clinical development programs. The role requires expertise in SDTM/ADaM, SAS or R, and cross-functional collaboration across teams.

The candidate will serve as Lead Statistical SME and participate in regulatory submissions, with a strong emphasis on data interpretation and high-quality analysis.

Qualifications

• Graduate degree in Statistics or related quantitative field.
• Proficiency in SAS or R programming.
• Excellent communication and 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, analysis, reporting, and interpretation of clinical trial data.
• Serve as the Lead Statistical SME, applying appropriate statistical methodologies in alignment with established procedures and regulatory expectations.
• Oversee statistical activities at the project level, including vendor oversight and ensuring compliance with statistical analysis and reporting standards.
• Collaborate cross-functionally and with external partners to support project success, publication strategies, and manuscript development.
• Provide statistical support for regulatory submissions and interactions with health authorities.

Skills

Biostatistics

SAS

R

CDISC

Statistical methods

Communication

Cross-functional collaboration

Education

PhD in Statistics or related field

MS in Statistics

Job description

Quality Talent Group is seeking a Lead Biostatistician to oversee biostatistics operations within clinical development programs. The role requires expertise in SDTM/ADaM, SAS or R, and cross-functional collaboration across teams.

The candidate will serve as Lead Statistical SME and participate in regulatory submissions, with a strong emphasis on data interpretation and high-quality analysis.