Collaborates with Clinical Development, Clinical Pharmacology, Regulatory and Clinical Operations expertise areas to design clinical trials.
Writes the statistical sections of clinical trial protocols, while consulting with internal and external experts
Contributes to or prepares statistical analysis plans and Data Presentation Plans
Collaborates with Data Management, Clinical Development, Clinical Pharmacology and Clinical Operations on design of eCRFs
Provides statistical guidance on conduct of ongoing trials
Collaborates with Statistical Programmers on summary and analysis of trial data. Writes and/or reviews ADS and ad hoc analysis specifications
Contributes to clinical study reports and other regulatory documents e.g. DSURs, Briefing Documents, etc.
Contributes to scientific articles, summarizing data collected in Alexion trials.
Participates in other activities and meetings to support Biostatistics and the Global Program Team as needed.
Consults with Research & Preclinical colleagues on statistical questions in their work.
Manages CRO statistical and programming support.
Qualifications
PhD in Biostatistics, Statistics, or equivalent with at least 4 years pharmaceutical biostatistics experience or MS with at least 6 years of relevant experience.
Excellent written and oral communication skills
Excellent presentation and interpersonal skills
Experience programming in SAS
Experience with simulations (design, implementation and interpretation)
Understanding of ICH GCP as well as general knowledge of industry practices and standards
Familiarity with R programming language and other statistical software, including EAST
Experience with CDISC, including SDTM, ADaM, CDASH
Flexible, well-organized, and possess the ability to work well under pressure.
The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.
