The Associate Director, Biostatistics oversees all biostatistics activities for multiple clinical programs to ensure timely and accurate delivery of statistical designs, analyses, and reports and regulatory submissions. Independently provides strategic statistical input to drug development including feasibility assessments, development plans, complex study designs, cross-study statistical methodology, interpretations, regulatory submissions and follow up. Contributes to establishing and driving compound level program functional strategy for resourcing, processes and standards to achieve quality and maximize efficiency. He/she works closely with Clinical Physicians, Clinical Operations, Safety, and Regulatory teams to plan and implement clinical studies as part of a larger clinical development plan, and to analyze and interpret clinical study data. This individual is also responsible for production of biostatistics deliverables, managing a team of internal and external biostatistics and statistical programming resources.
- Lead and manage team of internal and external biostatistics and statistical programming resources supporting studies and programs for identified therapeutic area(s) or phase(s) of development. Manage assignments and priorities of team members.
- Ensure accurate, statistically valid deliverables included in protocols, statistical analysis plans, study reports, manuscripts, and regulatory submission documents.
- Coordinate achievement of major statistical deliverables and milestones in collaboration with other functions.
- Leverage standardization to maximize global data integration and interpretability.
- Provide statistical leadership and support for feasibility assessments, clinical development plans, complex study designs, regulatory meetings, submissions and follow up.
- Responsible for providing statistical leadership for preparation of marketing applications (NDA/BLA) to FDA, EMA or other worldwide regulatory agencies.
- Keeps abreast of literature/advancements in science/medicine/technology in own and related fields of the drug development program.
- Monitors project progress and ensures proper resource allocation for successful project deliverables against goals and timelines.
- At least 8 years of pharmaceutical experience 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 including eCTD submissions
- working knowledge of major statistical software programs including SAS
- knowledge of CDISC requirements for SDTM and ADaM
- 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.
- A PhD in Statistics/Biostatistics
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.