- In collaboration with or under supervision of line manager or study statistician:
- provides support for design of clinical trials.
- 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 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.
- 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 EAST
- Knowledge 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 non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.
- PhD in Statistics/Biostatistics preferredwith exposure to clinical trials in pharmaceutical industry through internship or work experience
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Senior Statistician - Boston, United States - Alexion Pharmaceuticals
Description
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:
You will need to have:
We would prefer for you to have:
Date Posted
03-May-2024Closing Date
28-Jul-2024Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact Alexion participates in E-Verify.AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.
