Associate Director, Biostatistics

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

Position: Associate Director, Biostatistics

Salary Range: $145K-$160K

Location: Sommerset, NJ (Hybrid or Remote)

About Pharmaron

Pharmaron is a global contract research and manufacturing organization (CRO/CDMO) helping pharma and biotech companies bring new therapies to life. With over 25,000 employees worldwide across 28 locations in the US, UK, China, and Singapore, we support drug discovery through to manufacturing with fully integrated high-quality services.

We\'re proud of the impact we make and just last year, we supported 887 discovery projects, 1,100+ CMC programs, and 1,397 clinical trials across all phases. Our teams are involved in everything from small molecules, ADC\'s, biologics, and gene therapies and we work with more than 3,300 global customers. To learn more, visit www.pharmaron.com.

What You\'ll Do

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.

Key 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.

What We\'re Looking For

• 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.

Why Pharmaron?

Pharmaron is a premier service provider for the life sciences industry. Founded in 2004, Pharmaron has invested in its people and facilities and established a broad spectrum of research, development, and manufacturing service capabilities throughout the entire drug discovery, preclinical, and clinical development process across multiple therapeutic modalities, including small molecules, biologics, and CGT products. With over 25,000 employees and operations in the US, UK, China, and Singapore. Pharmaron has an excellent track record in delivering R&D solutions to its partners in North America, Europe, Japan, and China.

Collaborative Culture: You will thrive in our inclusive and collaborative environment, where teamwork and innovation go hand in hand. Here, your voice matters, and your contributions make a real impact. "Employees Number One" and "Clients Centered" are the core cultural values at Pharmaron. Our culture, which sets Pharmaron apart from other organizations, has evolved from our deep commitment to our employees, partners, and collaborators.

Benefits: As part of our commitment to your well-being, we offer a comprehensive benefits package:

• 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

About Pharmaron

Pharmaron (Stock Code: 300759.SZ/3759.HK) is a premier R&D service provider for the life sciences industry. Founded in 2004, Pharmaron has invested in its people and facilities, and established a broad spectrum of research, development and manufacturing service capabilities throughout the entire drug discovery, preclinical and clinical development process across multiple therapeutic modalities, including small molecules, biologics and CGT products. With over 19,000 employees, and operations in China, the U.S., and the U.K., Pharmaron has an excellent track record in the delivery of R&D solutions to its partners in North America, Europe, Japan and China.

Pharmaron is proud to be an Equal Employment Opportunity and Affirmative Action employer.