Associate Director, Biostatistics

Pharmaron • Franklin Township, NJ

1d • Hybrid

About The Position

The Associate Director, Biostatistics will provide strategic and operational leadership to the biostatistics team, ensuring the delivery of high-quality statistical support across Phase I–IV clinical studies. This role is responsible for overseeing the development and continuous improvement of SOPs, work instructions, templates, and processes to ensure compliance with ICH-GCP, applicable regulatory requirements, and industry standards while driving operational efficiency. The Associate Director will also provide expert statistical guidance on study design, protocol and CRF development, sample size calculations, statistical analysis plans, and clinical study reports, serving as a trusted advisor to clients and cross-functional teams.

Requirements

• Master's degree or higher in Biostatistics, Statistics, Mathematics, or a related scientific field preferred; Bachelor's degree with equivalent experience will also be considered.
• 7+ years of experience in clinical trial biostatistics.
• Expert knowledge of statistical methodologies and analyses with experience supporting clinical development programs.
• Strong understanding of the drug development process and applicable regulatory requirements, including NMPA, FDA, and ICH-GCP guidelines.
• Proven leadership skills with experience in project planning and execution, financial and risk management, quality oversight, and team development.
• Excellent communication and relationship-building skills with the ability to collaborate effectively across cross-functional teams, clients, and stakeholders.
• Highly organized, detail-oriented, and quality-driven, with a strong track record of meeting timelines and delivering reliable results.

Responsibilities

• Develop, review, and continuously improve SOPs, work instructions, templates, and processes to ensure compliance with ICH-GCP, regulatory requirements, quality standards, and industry best practices while driving operational efficiency.
• Oversee project execution by ensuring appropriate staffing, quality control, issue resolution, and the timely delivery of high-quality statistical services and project deliverables.
• Foster a collaborative, results-oriented work environment by promoting open communication, teamwork, and cross-functional collaboration across departments.
• Lead and support internal and external audits, ensuring timely resolution of audit findings and ongoing compliance with applicable regulations and quality standards.
• Support Business Administration and Business Development by reviewing project proposals and contracts while building and maintaining strong relationships with clients and vendors.
• Provide expert statistical consultation on clinical trial design, protocol and CRF development, sample size calculations, and other statistical considerations throughout the study lifecycle.
• Author and review statistical analysis plans, statistical reports, and statistical methodology sections for clinical protocols and reports across Phase I–IV studies in multiple therapeutic areas.
• Participate in departmental operational and management meetings, collaborate with senior leadership on staffing and strategic planning, and perform other duties as assigned.

Benefits

• Comprehensive Medical, Dental & Vision Insurance with significant employer contributions
• 401(k) Retirement Plan with generous employer matching
• Generous Paid Time Off (PTO), Paid Sick Leave & Company Holidays to support work-life balance
• Employer-funded Health Savings Account (HSA) contributions (for eligible plans), plus Healthcare & Dependent Care Flexible Spending Accounts
• 100% Employer-paid Employee Life Insurance, AD&D, Short- and Long-Term Disability Insurance
• Employee Assistance Program (EAP), mental health resources, and wellness programs
• Family-friendly benefits, including fertility support and maternity resources
• Professional development and career growth opportunities within a leading global CRO/CDMO

What This Job Offers

• Job Type: Full-time
• Career Level: Manager