Associate Director, Biostatistics
Lead biostatistics teams to design and analyze clinical trials, ensuring regulatory compliance and high-quality statistical deliverables for drug development programs.
- Compensation
- $145K–$160K / yr
- Location
- Franklin Township, NJ, US
- Work setup
- Not specified
- Seniority
- Not specified
- Employment
- Contract
- Experience
- 7+ years
- Category
- Not specified
- Posted
Skills
Must have
- 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.
Full 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 be 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.