Senior Biostatistician - Clinical Development & Submissions

Quality Talent Group; Springfield (NJ); On-site; USD 140,000 - 210,000; Full time

Benefits offered by this job

Competitive benefits

Paid time off

Health insurance

Retirement plan

EAP and well-being resources

Parental leave

Volunteer time

Learning & development

Job summary

A global consumer health and personal care company in New Jersey is seeking a Lead Biostatistician to oversee statistics operations for multiple clinical development programs. You will ensure high‑quality design, analysis, reporting, and interpretation of trial data, and act as the Lead Statistical SME in alignment with procedures and regulatory expectations.

Collaborate cross‑functionally with internal teams and external partners to support project success, publication strategies, and

Qualifications

• PhD in Statistics or related quantitative field; 4+ years with PhD, or 6+ years with MS.
• Strong background in clinical development biostatistics and regulatory standards.
• Proficiency in SAS or R and CDISC SDTM/ADaM.
• Excellent communication and cross-functional collaboration.

Responsibilities

• Lead and manage biostatistics operations for clinical programs.
• Serve as Lead Statistical SME and ensure regulatory compliance.
• Oversee project-level statistical activities and vendor oversight.
• Collaborate with internal and external partners for publications.
• Provide statistical support for regulatory submissions.

Skills

Biostatistics leadership

SAS

R programming

CDISC SDTM/ADaM

Regulatory submissions

Cross-functional collaboration

Education

PhD in Statistics or related field

MS in Statistics or related field

Tools

SAS

R

Job description

A global consumer health and personal care company in New Jersey is seeking a Lead Biostatistician to oversee statistics operations for multiple clinical development programs. You will ensure high‑quality design, analysis, reporting, and interpretation of trial data, and act as the Lead Statistical SME in alignment with procedures and regulatory expectations.

Collaborate cross‑functionally with internal teams and external partners to support project success, publication strategies, and