Director/Sr. Director Biostatistics

Job Description Summary

Director / Sr Director Biostatistics

This position will be located at East Hanover, New Jersey site and will not have the ability to be located remotely. This position will require 5-10% travel as defined by the business (domestic and / or international).

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 Immunology 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.

Key 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 the Global Program Team (GPT).
• 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).

Essential Requirements :

Desirable Requirements :

Salary Range : $185,500.00 - $344,500.00

Skills Desired : Automation, Biostatistics, Clinical Trials, Computer Programming, Cross-Functional Teams, Data Analytics, Data Strategy, Decision Making Skills, Global Project Management, Metadata Management, Statistical Analysis.

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Salary : $185,500 - $344,500