Principal Biostatistician

Quality Talent Group; New Providence (NJ); On-site; USD 140,000 - 200,000; Full time

Benefits offered by this job

Competitive benefits

Paid time off

Health insurance

Job summary

Quality Talent Group is seeking a Lead Biostatistician to steer biostatistics operations in our clinical development programs. You will apply advanced statistical methods and ensure regulatory-aligned analysis and reporting.

The role requires a PhD or MS in Statistics or related field with substantial experience in biostatistics, CDISC/ADaM, and SAS or R. Strong collaboration with cross-functional teams and external partners is essential for successful regulatory submissions.

Qualifications

• Graduate degree in Statistics or related quantitative field with 4+ years (PhD) or 6+ years (MS) industry experience.
• Strong background in clinical development biostatistics and regulatory processes.
• Proficiency in CDISC SDTM/ADaM datasets and FDA standards.
• Excellent communication and cross-functional collaboration skills.

Responsibilities

• Lead biostatistics operations for clinical development programs.
• Serve as Lead Statistical SME, applying appropriate methodologies.
• Oversee project-level statistical activities and vendor oversight.
• Collaborate with cross-functional and external partners for submissions.

Skills

Biostatistics expertise

Statistical methods

Cross-functional collaboration

SAS or R programming

Education

PhD in Statistics or related field

MS in Statistics or related 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.