The Senior 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 and business development opportunities to ensure that statistical elements are in line with the overall product strategy. Represent Biostatistics in meetings with cross-functional project teams, senior management, commercial, 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; 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.
- Contributes strategically to clinical development plans, regulatory strategies, and life cycle planning to ensure that the company's clinical programs are optimally designed and executed.
- Provides statistical consultations and strategic inputs in terms of drug development for company's senior management and other staff within the company.
- Assists in the development of study protocols, provides sample size estimates and power calculations for complex study designs, and oversees generation of randomization schedule for complex randomization schemes.
- Develops statistical analysis plans for studies, performs complicated statistical analyses, and oversees the generation of tables, listings and figures for study reports and manuscripts.
- Demonstrates proficiency with SAS statistical procedures, familiarity with specialized statistical software (e.g., S-PLUS, EaSt).
- Reviews regulatory documents for accuracy and appropriateness of statistical interpretations.
- Demonstrates ability to cultivate internal and external relationships based on trust and respect in anticipation of future working relationships; demonstrated ability to proactively maximize relationships to enable successful collaboration.
- Communicates effectively with internal team members, senior management, external experts and regulatory authorities.
- Demonstrates ability to provide coaching and feedback to foster professional development while also supporting business goals.
A PhD in Statistics/Biostatistics and at least 12 years of pharmaceutical experience including six (6) years of direct supervisory and management experience in the pharmaceutical research environment are preferred; candidates with a MS in Statistics/Biostatistics and 14-17 years experience will be considered. 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; experience leading BLAs/NDAs as well as interactions with FDA; interaction with EMA/CPMP and preparation of MAAs; working knowledge of major statistical software programs and at least one scientific programming language; 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.
Boston, MA, United States
Some opportunities happen only once in a lifetime - like a job where you have the extraordinary opportunity to change lives. At Alexion, such opportunities arise through our unwavering mission to serve patients and families affected by rare diseases. These patients are our guiding star, and we act with integrity, urgency, and discipline because we know their lives are at stake.
Alexion is a global biopharmaceutical company focused on serving patients and families affected by rare diseases through the discovery, development and commercialization of life-changing therapies. As the global leader in complement biology and inhibition for more than 20 years, Alexion has developed and commercializes the first and only approved complement inhibitor to treat patients with paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), and anti-acetylcholine receptor (AchR) antibody-positive generalized myasthenia gravis (gMG). Alexion also has two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare metabolic disorders, hypophosphatasia (HPP) and lysosomal acid lipase deficiency (LAL-D). In addition, the company is developing two late-stage therapies, a second complement inhibitor and a copper-binding agent for Wilson disease. Alexion focuses its research efforts on novel molecules and targets in the complement cascade and its development efforts on the core therapeutic areas of hematology, nephrology, neurology, and metabolic disorders. Alexion has been named to the Forbes list of the World's Most Innovative Companies seven years in a row and is headquartered in Boston, Massachusetts' Innovation District. The company also has offices around the globe and serves patients in more than 50 countries.
Alexion's aspiration is to be the most rewarding place to work, where people are empowered to make a difference and where diversity of backgrounds and ideas is encouraged. We are looking for talented individuals who share our passion and commitment to change the lives of patients with rare diseases. We hope you will consider joining our team. Further information about Alexion can be found at: www.alexion.com.
As a leading employer in our industry, Alexion is proud to offer a highly competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits include group medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more.