Lead Biostatistician, Clinical Development & Submissions

Quality Talent Group; Summit (NJ); On-site; USD 140,000 - 190,000; 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

Adoption, fertility, and surrogacy"

Global parental leave

Paid company holidays

Learning and development opportunities

Job summary

Quality Talent Group in Summit, NJ, seeks a Lead Biostatistician to oversee biostatistics operations across clinical development, ensuring robust design, analysis, and reporting of trial data.

You will serve as the Lead Statistical SME, applying state-of-the-art methods, supervising project-level activities, and coordinating with vendors and external partners to support regulatory submissions and manuscript development.

Qualifications

• Graduate degree in Statistics or related quantitative field; typically 4+ years industry experience with a PhD or 6+ years with an MS.
• Strong background in clinical development biostatistics, statistical methods, and industry processes.
• Proficiency in SAS or R programming.
• Excellent communication, collaboration, problem-solving, and interpersonal skills; effective working in cross-functional teams.
• Advanced knowledge of working with CDISC and related FDA standards for the specification and creation of SDTM and ADaM datasets.

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

SAS

R programming

CDISC

Regulatory knowledge

Cross-functional collaboration

Education

Graduate degree in Statistics or related quantitative field

Tools

SAS

R

Job description

Quality Talent Group in Summit, NJ, seeks a Lead Biostatistician to oversee biostatistics operations across clinical development, ensuring robust design, analysis, and reporting of trial data.

You will serve as the Lead Statistical SME, applying state-of-the-art methods, supervising project-level activities, and coordinating with vendors and external partners to support regulatory submissions and manuscript development.