Associate Director, Biostatistics

Ecrscorp; Bridgewater Township (NJ); Hybrid; USD 120,000 - 160,000; Full time

Job summary

A leading contract research organization is seeking an Associate Director of Biostatistics to manage clinical trial programs and lead statistical teams. The ideal candidate will have a Ph.D. or Master’s degree with extensive experience in statistical methodologies and a proven track record in biostatistics. This role offers flexibility to work onsite or remotely within the USA, focusing on quality and compliance in drug development.

Qualifications

• At least 10 years of relevant experience with a Ph.D. or 13 years with a Master’s.
• Exceptional ability and performance demonstrated.

Responsibilities

• Manage clinical trial programs/projects and lead statistical teams.
• Ensure compliance with regulatory standards and interact with regulatory agencies.
• Contribute to protocol design and perform statistical analysis.

Skills

Leadership

Statistical Methodologies

Collaboration

Education

Ph.D. in Statistical Science

Master’s Degree

Job description

Everest Clinical Research ("Everest") is a full-service contract research organization (CRO) providing a broad range of expertise-based clinical research services to pharmaceutical, biotechnology, and medical device industries worldwide. We serve leading companies and work with advanced drugs, biologics, and medical devices in development.

Founded in 2004, Everest has a strong foundation as a statistical and data management center of excellence and has evolved into a full-service CRO. Our headquarters are in Markham, Ontario, Canada, with additional sites in Bridgewater, New Jersey, USA; Shanghai, China; and Taipei, Taiwan.

Our core values include quality, customer focus, and flexibility.

We are seeking a dedicated, skilled, and customer-oriented individual to join our team as Associate Director, Biostatistics (Statistical Operations). This position can be based onsite in Bridgewater, New Jersey, or remotely from anywhere in the USA in accordance with our Work from Home policy.

Key Accountabilities:

1. Manage clinical trial programs/projects, providing technical and operational leadership.
2. Coach, mentor, and review work of biostatisticians and statistical programmers.
3. Conduct performance reviews and developmental planning for team members.
4. Lead statistical and programming teams, collaborating with clients and internal teams.
5. Ensure the application of sound statistical methodologies in study design and analysis.
6. Contribute to protocol design and development, including writing trial protocols and research proposals.
7. Serve as a principal Biostatistician, contributing strategically to drug development and commercialization.
8. Review clinical data management deliverables and statistical analysis plans.
9. Perform hands-on statistical analysis and maintain expertise in statistical methodologies and regulatory requirements.
10. Validate statistical outputs and ensure quality control of deliverables.
11. Provide statistical consultation for publications and participate in writing scientific documents.
12. Act as a mentor to less experienced biostatisticians.
13. Ensure compliance with regulatory standards and interact with regulatory agencies.
14. Manage statistical resources, capacity analysis, and performance metrics.
15. Participate in organization development, business development, and project budget planning.
16. Assist with out-of-scope service tracking and change order drafting.

Qualifications and Experience:

Ph.D. in statistical science, mathematics, or related field with at least 10 years of relevant experience, or a Master’s degree with at least 13 years of relevant experience.

Demonstrated exceptional ability and performance.

For more information about Everest and other opportunities, visit www.ecrscorp.com.

We thank all applicants; only those selected for an interview will be contacted.

Everest is committed to diversity and equal opportunity. We welcome applications from individuals with disabilities and will provide accommodations upon request.