Director, Biostatistics

Position Summary

The Director, Biostatistics will lead Biostatistics support for one or multiple therapeutic areas to ensure that Company Research and Development projects are optimally strategized, correctly designed, properly analyzed and clearly presented to support new product development, domestic and international regulatory submissions, and the maintenance and growth of existing products. Accountable directly or through subordinates for the statistical strategy and design in all projects in their therapeutic area(s) for full compound development and product life cycle. Provides input to clinical development plans, protocols, clinical study reports, regulatory submission materials, abstracts, and manuscripts to ensure that statistical elements are in line with the overall product strategy. Represent Biostatistics in meetings with cross-functional project teams and regulatory agencies. Additional essential functions of this position include: ensuring adherence to ICH guidelines, Good Clinical Practices, and regulatory requirements by contributing to SOP development and training; leading in the development and adaptation of new statistical methodology in support of drug research and development as required; keeping current with regulatory guidance and requirements in the global environment; hiring, mentoring and managing employees to maintain a competent and qualified staff; selecting and hiring qualified and cost-effective CRO's to supplement internal resources; and monitoring the performance of CRO's to ensure high quality products and services.

Principal Responsibilities

• Plans, organizes, and directs the activities of Biostatistics to support one or more therapeutic
• areas to ensure that Alexion's clinical programs are optimally designed, properly analyzed and
• clearly presented to support new product development, domestic and international regulatory submissions, and the maintenance and growth of existing products
• Participates in establishing and maintaining policies, standards, and procedures for global Biostatistics
• Leads in development and adaptation of new statistical methodology in support of research and development, keeping current with regulatory guidance and requirements in the global environment.
• Provides statistical consultations and strategic inputs in terms of drug development for cross-functional teams within the company.

Qualifications

• A PhD in Statistics/Biostatistics and 10 years of pharmaceutical experience or MS in Statistics/Biostatistics and 12 years of pharmaceutical experience including four (4) years of supervisory and management experience in the pharmaceutical research environment are preferred. The successful candidate must also possess the following: comprehensive knowledge of statistical methodology in design and analysis, and regulatory requirements relating to clinical development of drugs and biologics; BLA/NDA experience as well as past interaction with FDA; interaction with EMA/CPMP and preparation of MAA; working knowledge of major statistical software programs and at least one scientific programming language; knowledge of CDISC requirements for SDTM and ADaM; excellent analytical, problem-solving and computer skills; excellent verbal and written communication skills, and excellent inter-personal skills. The qualified applicant must also be flexible, well-organized, and have the ability to work well under pressure.

Education

• A PhD in Statistics/Biostatistics is preferred