This is what you will do:
The Senior Statistician, Biostatistics provides statistical support for clinical trials, including but not limited to the following: contributing to trial designs, authoring statistical sections of protocols, preparing statistical analysis plans, and reviewing and interpreting the analysis of clinical trial data.You will be responsible for:
In collaboration with or under supervision of line manager or study statistician:
provides support for design of clinical trials.
You will need to have:
- contributes to writing 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
- provides support 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 specificationscontributes to clinical study reports and other regulatory documents e.g. DSURs, Briefing Documents, etc.contributes to scientific articles, summarizing data collected in Alexion trials.
- consults with Research & Preclinical colleagues on statistical questions in their work.
- Manages CRO statistical and programming support.Participates in other activities and meetings to support Biostatistics and the Global Program Team as needed.
PhD in Biostatistics, Statistics, or equivalent or MS with at least 2 years of relevant pharmaceutical 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 EASTKnowledge of 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 nonlinear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.We would prefer for you to have:
PhD in Statistics/Biostatistics preferred with exposure to clinical trials in pharmaceutical industry through internship or work experience