At Biogen, we offer a workplace that is unique, connected, resilient and impactful. Our purpose to find cures for rare diseases is a unique focus within our industry. We are connected as a team by this shared purpose, the pride we have in our work, and the inspiration we obtain from the lives we’re changing. We are resilient as we overcome obstacles, following the science to deliver for our patients. Most of all, our work allows us to have an impact. An impact on our patients’ lives and on changing the course of medicine.
About this Role
As the Principal Biostatistician, you are responsible for providing and supporting study design and data analysis in clinical development, biomarker development, research, BTMS or PO&T. You support Biostats SMT biostatistician, provide statistical input in the scientific discussion, participate in the development of study protocols including participation in study design discussions. You also review study setup activities including but not limited to randomization, CRFs, and may serve as primary biostatistician at study level. You develop statistical analysis plans including data and report specifications, perform statistical analyses, interpret statistical results, and co-author clinical study reports. You contribute to internal decision making, publications of the clinical data, and integrated summaries for regulatory submissions. You also keep up to date on current methodology research and conducts methodology research
What you’ll do
- Support SMT Biostatistician to provide statistical expertise and operational
- Provide statistical support in the development of the study synopsis, protocol, statistical analysis plan, clinical study report, and other regulatory submission documents, ensuring accurate and statistically valid deliverables.
- Analyze and communicate study level resource and quality issues that may impact deliverables or timelines. Propose and implement solutions. Escalate issues to management as appropriate.
- Explore alternative analysis methodology and data presentation techniques. Performs modelling and simulations to identify solutions for complex statistical issues.
- Support the development and implementation of ADS standards. Participates in process improvement initiatives.
- PhD in Statistics/Biostatistics or equivalent without working experiences or Master degree in Statistics/biostatistics or equivalent with a preferred 3+ years of relevant experiences
- Understanding of statistical principles and clinical trial methodology with the ability to practice and implement them.
- Ability to provide solutions to a variety of technical problems of moderate scope and complexity.
- Some knowledge of medical/biological terminology and clinical trial designs
- Conversant with statistical programming languages and software, including SAS, and computing tools for modelling and simulations
- General project management skills.
Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.
All your information will be kept confidential according to EEO guidelines.