Director / Senior Director Biostatistics

Novartis-posted 4 days ago

Full-time • Director

Onsite • East Hanover, MA

5,001-10,000 employees

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As the Director/Sr Biostatistics, you will influence and drive statistical strategy/innovation directly taking part in cross-functional collaboration and decision making for program(s) across multiple indications/ therapeutic/ disease areas within drug development in the Cardio Renal Metabolic Development Unit. You will lead and integrate input from different quantitative scientists impacting clinical development, health authority interactions, represent the Advanced Quantitative Sciences function at internal and external decision boards, develop and mentor other statisticians, and provide strategic, technical, operational and scientific leadership and solutions to the organization.

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).

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

Proven people leadership ability and expert skills in building partnerships and collaborations.

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