Alexion Pharmaceuticals, Inc.
Responsible for creating and leading an integrated Quantitative Sciences function incorporating Biostatistics, Programming, and Medical Writing across all Alexion clinical programs spanning all phases of Clinical Development, including analytical support for Regulatory submissions, Global Medical Affairs initiatives, and Pricing & Reimbursement applications. Accountable to deliver both numerically and textually the data capture requirements (protocols, statistical analysis plans) and data reporting (tables/listings/figures, study reports, submissions). Provide expertise and guidance in clinical drug development and study design to ensure development programs are optimized and studies are correctly designed, analyzed, and reported.
Job Duties & Responsibilities
Create and lead an integrated Quantitative Sciences function incorporating Biostatistics, Programming, and Medical Writing across all Alexion clinical programs spanning Phase I through Phase IV.
Deliver both numerically and textually the data capture requirements (protocols, amendments, statistical analysis plans) and data reporting (tables/listings/figures, study reports, clinical submission documents).
Provide expertise and guidance in clinical study design and institute best practices with regard to planning, execution, interpretation, and reporting for clinical projects and studies that span the disciplines of clinical development and medical affairs, as well as post-marketing initiatives. Support preclinical and bioanalytical assay study design.
Contribute strategically to clinical development plans, regulatory strategies, and life cycle planning through governance and oversight of subordinates to ensure that the company's clinical programs are optimally designed, analyzed, and summarized.
Drive execution of deliverables through a largely outsourced operating model. Implement strategies to optimize external support with Contract Research Organizations or other external resources globally.
Provide statistical consultations and strategic inputs in terms of drug development for company's executive management and other staff within the company. Represent the function externally where required e.g. Advisory Committees.
Lead the development and adaptation of new statistical methodology in support of drug research and development as required and keep current with regulatory guidance and requirements in the global environment with a focus on rare diseases.
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.
Communicate effectively with internal team members, senior and executive management, external experts and regulatory authorities.
Accountable for the functional budget and for building and developing a highly effective team.
PhD in Statistics/Biostatistics and 15 years’ of pharmaceutical experience including ten (10) years' of supervisory and management experience in the pharmaceutical research environment;
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; Similar experience with other major health authorities;
Experienced enterprise leader capable of integrating across functional boundaries;
Experience implementing Bayesian and adaptive approaches in study design and analysis;
Excellent analytical and problem-solving skills;
Excellent verbal and written communication skills, and excellent inter-personal skills;
Flexible, well-organized, and able to work well under pressure.
Experience in rare disease clinical drug development;
Experience partnering and managing CRO relationships and other external resources;
Experience with overall planning, development, and contribution to deliverables for global clinical trials and regulatory submissions
Working knowledge of major statistical software programs and at least one scientific programming language; *LI-CS1
Boston, MA, United States
Alexion is a global biopharmaceutical company focused on developing and delivering life-transforming therapies for patients with devastating and rare disorders. Alexion developed and commercializes Soliris® (eculizumab), the first and only approved complement inhibitor to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), two life-threatening ultra-rare disorders. As the global leader in complement inhibition, Alexion is strengthening and broadening its portfolio of complement inhibitors, including evaluating potential indications for eculizumab in additional severe and ultra-rare disorders. Alexion’s metabolic franchise includes two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare disorders, Strensiq® (asfotase alfa) to treat patients with hypophosphatasia (HPP) and Kanuma™ (sebelipase alfa) to treat patients with lysosomal acid lipase deficiency (LAL-D). In addition, Alexion is advancing the most robust rare disease pipeline in the biotech industry, with highly innovative product candidates in multiple therapeutic areas.
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. To learn more about Alexion, please visit www.alexionpharma.com or download our App for iPhones and Blackberries.
Alexion is an Equal Opportunity /Affirmative action employer
Apply for this job at https://alexion.contacthr.com/60524155
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Alexion Pharmaceuticals, Inc.
Website : http://www.alexion.com
Alexion Pharmaceuticals, Inc. is a global biopharmaceutical company focused on developing and delivering life-transforming therapies for patients with severe and life-threatening diseases that are also ultra-rare. Patients with these devastating diseases often have no effective treatment options, and they and their families suffer with little hope.