Senior Director Biostatistics
About The Position
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. About the Role Your Key Responsibilities:
Requirements
- 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
Nice To Haves
- Proven people leadership ability and expert skills in building partnerships and collaborations.
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).
Benefits
- US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits.
- In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.
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What This Job Offers
Job Type
Full-time
Career Level
Director
Industry
Chemical Manufacturing
Education Level
Ph.D. or professional degree
Number of Employees
5,001-10,000 employees
