Senior Director Biostatistics

Role Summary

Senior Director Biostatistics. Onsite in East Hanover, New Jersey.

Responsibilities

• Ensure expert level contribution to strategy (design, analysis/synthesis, interpretation and reporting, health authority response, negotiating with pricing agencies, influence and implement publication strategy, quantitative decision making) for critical studies in a program
• Strategic statistical input and influence into one or more projects (development plan, dose-finding strategy, regulatory strategy, publication strategy, pricing & reimbursement strategy, statistical deliverables).
• Lead collaborations with clinical, regulatory and other strategic functions to drive quantitative decision making in drug development and enable successful impact on robust drug development plans
• Collaborate across functions to ensure timeliness and quality of statistical deliverables
• Propose and implement innovative designs and methods to optimize drug development.
• Represent all functions within Advance Quantitative Sciences (Biostatistics, Pharmacometrics, Statistical Programming) at project meetings
• Plan, prioritize and oversee project level activities and ensure efficient resource management within or across franchise and effective partnership with vendors.
• Lead the review and implementation of health authority guidance.
• Represent biostatistics in interacting with external experts (statistical, clinical, and technical).

Qualifications

• MS (in Statistics or equivalent) with 12+ years relevant work experience or PhD (in Statistics or equivalent) with 8+ years relevant work experience
• Has advanced knowledge of applying statistics and innovative approaches
• Expert knowledge in a variety of statistical areas
• Experience in outcome trials
• Record of successful implementation of novel methods and/or innovative strategies in drug development
• Extensive knowledge of drug development and HA guidelines
• Strong understating of at least one disease area
• Fluent English (oral and written)
• Strong interpersonal and communication skills bridging scientific and business needs

Skills

• Proven ability in statistical strategy development and cross-functional leadership

Education

• MS or PhD in Statistics or equivalent