Principal Biostatistician

Quality Talent Group; Chatham (NJ); On-site; USD 150,000 - 210,000; Full time

Benefits offered by this job

Excellent health benefits

Paid time off

Retirement plan

EAP & well-being resources

Learning and development opportunities

Job summary

Quality Talent Group is seeking a senior Biostatistician Lead to oversee biostatistics operations in our global clinical development programs. You will act as the Lead Statistical SME, guiding the design, analysis, and interpretation of trial data in collaboration with cross-functional teams.

The role requires a PhD in Statistics or a related field (or a MS with substantial experience), strong proficiency in SAS or R, and deep familiarity with CDISC standards for SDTM/ADaM datasets.

Qualifications

• Graduate degree in Statistics or related quantitative field; typically 4+ years with PhD or 6+ years with MS.
• Strong background in clinical development biostatistics and regulatory standards.
• Proficiency in SAS or R programming.
• Excellent communication and cross-functional 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 and analysis of trial data.
• Serve as Lead Statistical SME, applying appropriate methodologies per procedures and regulatory expectations.
• Oversee project-level statistical activities including vendor oversight and adherence to standards.
• Collaborate with internal teams and external partners to support publications and manuscript development.
• Provide statistical support for regulatory submissions and interactions with health authorities.

Skills

Biostatistics

SAS

R

CDISC standards

Regulatory submissions

Cross-functional teamwork

Communication

Education

PhD in Statistics or related field

MS in Statistics (6+ years experience)

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.