Principal Biostatistician

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

Overview:

Recognized in 2024 by Seramount as one of the 100 Best Companies for Working Parents and Caregivers, the company also earned a place on the 2024 US Inclusion Index and Global Inclusion Index across 7 countries - Brazil, Canada, China, Germany, India, Japan, and the UK.

This is a global organization in the consumer health and personal care industry, with 135+ years of heritage, 22,000+ employees, and a presence across 100+ countries. Its portfolio includes iconic consumer health and personal care brands used by millions of people worldwide.

Benefits:

• Competitive benefits package.
• Paid time off.
• Health insurance benefits, including coverage for doctor visits and mental health care.
• Retirement program.
• Employee Assistance Program (EAP) and mental well-being resources.
• Global exercise/well-being reimbursement.
• Adoption, fertility, and surrogacy benefits.
• Global parental leave.
• Paid company holidays and volunteer time.
• Learning and development opportunities.

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.