Senior Specialist, Statistician - Alexion Technical Operations (ATO)
Alexion Global Technical Operations team is seeking a dynamic and expert individual for the role of Senior Specialist, Statistician. This role offers an exciting opportunity to provide statistical subject matter expertise and advice to the Technical, Regulatory and Quality teams who support manufacturing of our commercial portfolio of products, particularly Biologics and Small Molecules. The successful candidate will help craft the evolution of Alexion’s Data Analytics and Digital roadmap!
This is what you will do:
You will lead the statistical analysis and interpretation of data from various sources, including data related to Biologics and Small Molecules, to support decision-making in Alexion Operations.
You will make recommendations to Scientists and Engineers on appropriate statistical methodologies to begin complex problems, quantify risk and help support a solution. You will provide statistical input in major process or product investigations, product shelf-life evaluations, and specification settings.
You will also actively contribute to the design of experiments, ensuring that they are statistically sound and meet the objectives. Your role will also involve providing statistical training and mentoring to team members and colleagues as needed.
You will be responsible for:
Ensuring the quality and accuracy of statistical analyses and reports
Aligning with International Council for Harmonisation (ICH) guidelines in all statistical work
Interpreting statistical results and translating them into comprehensible terms for decision-maker
Participating in strategic initiatives and projects, providing statistical insights and recommendations
Providing statistical expertise in the planning, design, and analysis of experiments
Supporting the evolution of the Data Analytics and Digital roadmap
Cultivating a data analytics culture by leading and facilitating training on Stat tools, sharing standard methodologies (including authoring relevant procedures, guidelines, work instructions) and leading by example
Assuming direct line management responsibilities, if assigned, which includes conducting performance reviews, setting and reviewing objectives regularly, offering guidance and mentoring, and developing and reviewing training and career development plans as required
You will need to have:
A master’s degree in Statistics, Mathematics, or a related field
3 years of shown experience in statistical analysis within pharma
Proficiency in using JMP or equivalent for data modelling and analysis.
Strong written and verbal communication skills to effectively translate statistical concepts to non-statisticians.
A good understanding of ICH guidelines and GMP manufacturing
Strong collaboration skills, with the ability to work well with cross-functional teams.
A proactive approach to problem-solving, with strong decision-making skills
Shown experience in leading teams and projects, along with conducting performance reviews, setting objectives, and developing training and career plans.
We would prefer for you to have:
Experience in authoring protocols and reports with regard to stability and comparability.
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
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