Director, Biostatistics

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.

About the role

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.

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.

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.

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

Pay

$165K-$180K

Location: Remote