Senior Associate Director, Biostatistics (Hybrid/Remote)

Pharmaron; New Jersey; Hybrid; USD 145,000 - 160,000; Full time

Benefits offered by this job

Medical, Dental & Vision Insurance

401(k) Retirement Plan with employer-m

Paid Time Off & Holidays

Health Savings Account (HSA)

Life Insurance

Employee Assistance Program (EAP)

Fertility and maternity resources

Career development opportunities

Job summary

Pharmaron is seeking an Associate Director, Biostatistics in Sommerset, NJ. This role provides strategic and operational leadership of the biostatistics team across Phase I–IV studies, ensuring high-quality statistical support and SOP/process improvement to boost efficiency.

The position requires an advanced degree in biostatistics and 7+ years of experience, with strong knowledge of regulatory guidelines (FDA, ICH-GCP) and excellent communication for client and team collaboration.

Qualifications

• Master's degree or higher in Biostatistics or related field; Bachelor's with equivalent experience considered.
• 7+ years of experience in clinical trial biostatistics.
• Expert knowledge of statistical methodologies for clinical development.
• Strong understanding of drug development process and regulatory requirements (FDA, ICH-GCP).
• Proven leadership in project planning, financial and risk management, quality oversight, and team development.
• Excellent communication and ability to collaborate across cross-functional teams.

Responsibilities

• Develop, review, and improve SOPs, work instructions, templates, and processes; ensure ICH-GCP compliance and efficiency.
• Oversee project execution, staffing, quality control, issue resolution, and on-time delivery of statistical services.
• Foster a collaborative environment with cross-functional teams and stakeholders.
• Lead internal and external audits, ensuring timely resolution of findings and compliance.
• Support business development by reviewing proposals and contracts and maintaining client/vendor relationships.
• Provide statistical consultation on trial design, sample size, SPAs, and lifecycle considerations.
• Prepare and review statistical analysis plans, reports, and methodology sections for protocols and reports.

Skills

Leadership

Communication

Project management

Cross-functional collaboration

Attention to detail

Education

Master's degree in Biostatistics

Bachelor's degree with equivalent experience

Job description

Pharmaron is seeking an Associate Director, Biostatistics in Sommerset, NJ. This role provides strategic and operational leadership of the biostatistics team across Phase I–IV studies, ensuring high-quality statistical support and SOP/process improvement to boost efficiency.

The position requires an advanced degree in biostatistics and 7+ years of experience, with strong knowledge of regulatory guidelines (FDA, ICH-GCP) and excellent communication for client and team collaboration.