Manager, Biostatistics

Some opportunities happen only once in a lifetime - like a job where you have the chance to change lives. At Alexion, people living with rare and devastating diseases are our Guiding Star. We are driven to continuously innovate and create meaningful value in all we do to help patients and families fully live their best lives. We value the uniqueness and diversity of our employees and recognize that nurturing the diverse perspectives and strengths of our people translates into innovative breakthroughs for patients.

**This is what you will do**:
The Manager Biostatistics is responsible (under supervision) for statistical activities in support of 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 line manager or study statistician, collaborates with Clinical Development, Clinical Pharmacology, Regulatory and Clinical Operations expertise areas to design clinical trials.
- In collaboration with line manager or study statistician, writes the statistical sections of clinical trial protocols, while consulting with internal and external experts
- In collaboration with line manager or study statistician, 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.

**You will need to have**:

- PhD in Biostatistics, Statistics, or equivalent with at least 2 years pharmaceutical biostatistics experience or MS with at least 4 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.

**We would prefer for you to have**:

- PhD in Statistics/Biostatistics preferred.

AstraZeneca completed its acquisition of Alexion, marking the creation of Alexion, AstraZeneca Rare Disease. If you're interested in career opportunities with AstraZeneca, click here.