Alexion Pharmaceuticals

Biostatistician II/III, Depending on Experience

Summary

Responsibilities:

This position is responsible for the statistical support of drug development programs from preclinical to regulatory submission. The major area of responsibility will include the design, analysis and reporting of the series of clinical studies required by these programs. Other activities include providing statistical consultation for the preclinical and drug discovery projects within the company.

• Interact with project team to plan and identify goals for individual drug development programs.
• Work with the regulatory staff to plan and conduct successful interactions with the FDA to ensure efficient progression of Alexion’s drug development programs.
• Serve as a member of interdisciplinary teams conducting clinical trials and assembling reports of trial results that meet regulatory requirements.
• Design of clinical trials, beginning with identification of clinical goals, statistical endpoints, planned analysis methodologies, power and sample size calculations and data management procedures.
• Analysis of clinical trials, starting with the compilation of detailed analysis plans, programming of validated and accurate analysis generation software, review of results with Alexion management and report writing.
• Provide statistical consultation for the drug discovery and preclinical research activities of the company.
• Management of external contract services required for support of Alexion drug development projects.

Requirements

An advanced degree in statistics or related discipline and at least 3 years of experience in the pharmaceutical/biotechnology industry.

• This individual must be proficient with the SAS software system and particularly strong with the statistical analysis methodologies implemented within SAS.
• Extensive knowledge of FDA regulatory requirements for drug development programs is a major plus.

About Alexion Pharmaceuticals

Alexion Pharmaceuticals, Inc. is a biopharmaceutical company working to develop and deliver life-changing drug therapies for patients with serious and life-threatening medical conditions. Employing more than 500 people worldwide, Alexion is engaged in the discovery, development and commercialization of therapeutic products aimed at treating patients with a wide array of severe disease states, including hematologic and kidney diseases, transplant, cancer, and autoimmune disorders. Soliris^(R) (eculizumab) is Alexion's first marketed product for patients with paroxysmal nocturnal hemoglobinuria (PNH) a rare, debilitating and life-threatening blood disorder defined by the destruction of red blood cells, or hemolysis. Soliris is approved in the U.S. and Europe in 2007, and Canada and Australia in 2009. Alexion is evaluating other potential indications for Soliris as well as other formulations of eculizumab for additional clinical indications, and is pursuing development of other antibody product candidates in early stages of development.

Alexion offers a highly competitive package of base and incentive compensation, group healthcare coverage, tuition reimbursement, relocation assistance, and a 401(K) plan.

Alexion is an Equal Opportunity/Affirmative Action Employer.

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