Director, Biostatistics

Pharmaron • Franklin Township, NJ

12d • $170,000 - $185,000 • Remote

About The Position

Pharmaron is seeking an experienced Director of Biostatistics to provide scientific and operational leadership for our growing Biometrics organization. This is a highly visible role responsible for providing strategic statistical expertise across Phase I-IV clinical trials. The successful candidate will partner with cross-functional teams and clients to ensure the delivery of high-quality statistical solutions that support successful clinical development programs.

Requirements

• Master's degree or higher in Biostatistics, Statistics, Mathematics, or a related scientific discipline (Bachelor's degree with equivalent experience will also be considered).
• 8+ years of clinical biostatistics experience supporting clinical trials.
• Experience authoring Statistical Analysis Plans and providing statistical input for clinical trial design.
• Strong knowledge of ICH-GCP, regulatory requirements, and clinical trial methodology.
• Excellent communication and client-facing skills with the ability to collaborate across scientific, operational, and commercial teams.

Responsibilities

• Develop, review and improve SOPs, working instructions, standard templates and procedures to ensure all activities in accordance with internal and external quality standards, SOPs/WIs, ICH-GCP and/or any other applicable local and international regulations, guidelines and industry standards and improve productivity and efficiency of the team.
• Maintain a positive, collaborative, results orientated work environment, build partnerships and teamwork, communicate to team in an open, transparent and objective manner.
• Participate in and responsible for the internal and external audits, take the appropriate actions to the audit findings timely.
• Provides support to Business Administration and Business Development, review project proposal and contract.
• Establishes and maintains relationships with clients and vendors.
• Provide statistical inputs/consultants on trial design, protocol and CRF development, perform sample size calculation, interact with clients with regard to statistical issues.
• Authoring and review of statistical analysis plans, statistical reports and statistical methodology sections in clinical protocols and reports in different therapeutic areas from phase I to phase IV.
• Attend the regular department operational and management meetings, meets regularly with VP to discuss staffing for upcoming studies and department development strategies.

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: Director