Senior Director Biostatistics
Novartis
Full-time
On-site
East Hanover, NJ
$185,500 - $344,500 USD yearly
Clinical Research and Development
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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