Join us as a Senior Biostatistician and you'll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients' lives. Late RIA (Respiratory, Inflammation, and Autoimmunity) within R&D Biopharmaceuticals drives late-stage development of our innovative pipeline, transforming exciting science into valued new medicines and ensuring patients around the world can access them.
RIA Biometrics department is an integral part of Late RIA and drives good design by generating the data needed for quality decision making. The goal of RIA Biometrics is to deliver value to the pipeline by excellence in delivery, improving decision making, and engaging and shaping the external environment whilst accessing and implementing innovative solutions.
RIA Biometrics oversee and deliver the statistical contribution to design, decision-making, analysis, interpretations, and communication (internally and externally) of the RIA portfolio of R&D Biopharmaceuticals and is engaged in shaping the TA external environment. This opportunity is within our Respiratory Therapeutic Area, however experience in that area is not essential.
Successful candidates will be located in Gaithersburg MD, Cambridge UK or Gothenburg Sweden. Work authorization in respective countries is required.
In this role you will provide statistical expertise for complex design and interpretation of clinical studies, regulatory submissions, and commercialization. You will also act as a coach/guide for less experienced statisticians in the production of analysis, supporting graphics and output tables for CSRs, GMA studies or publications.
You will also:
- Analyze internal and external information to inform design decisions and the development of decision criteria
- Develop a Statistical Analysis plan for complex studies and/or project deliveries
- Provide support to the complex study analysis, regulatory submissions including specification of overview documents and response to regulatory questions
- Contribute to the regulatory submissions including specification of overview documents and response to regulatory questions
- Identify opportunities for the application of modelling and simulation to improve study design
- Identify and apply statistical methodology to improve the process and delivery activities
- Perform ad hoc and exploratory data analyses
- Contribute to the development of best practice to improve quality, efficiency and effectiveness
- MS/PhD in Statistics, Biostatistics, or Mathematics (containing a substantial statistical component)
- Experience working within a statistical role, preferably in pharma/healthcare or other relevant area
- Knowledge of the technical and regulatory requirements related to the role and able to guide others on these
- Experience in drug development, study design, and data analysis and interpretation
- Excellent communication skills and ability to build strong relationships
- Excellent collaboration skills required – the energy to work across global & functional boundaries, both internally and externally
- Project management skills
- Ability to apply statistical expertise to complex problems, problem solving and quality focus
- Experience in respiratory product development
- Coaching skills
- Experience in commercial or early development support work
- Expert statistical programming skills (SAS and R)
Next Steps -- Apply today!
To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience -- it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.
Competitive salary and benefits.
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 authorisation and employment eligibility verification requirements.