We are looking for a Biostatistician who is passionate about their profession and inspired by being part of a team, working in life sciences, to bring a therapy to patients. This is an opportunity to make an impact while being part of a historically significant company that is making a difference to the lives of millions of people.
Reporting to the Head of Translational Data Sciences and Advanced Analytics will provide expertise in statistical methodology, including complex data analysis, Design of Experiments, Quality by Design and statistical training to support Quality, and Manufacturing functional groups.
- Possesses an advanced understanding of modern drug discovery and development processes. Represents Biostatistics as a member of clinical trial teams, providing strategic input and expert technical guidance to team members.
- Is responsible for all scientific and operational statistical work for multiple clinical trials, observational studies, or real world data (RWD) investigations.
- Perform highly complex statistical data analysis on projects including multivariate data analysis, categorical data analysis, simulation, and time series data analysis.
- Ensure all statistical methods comply with regulations, guidance and standards
- Collaborate in the design, development, and implementation of new SOPs, processes and statistical methodologies, and provide training to cross functional teams.
- Develop statistical programming and manage projects to meet deliverables and milestones.
- Design experiments for assay development, troubleshooting, research and process capability.
- Represent organization as the primary statistical contact on projects.
- Author clinical protocols and biostatistical sections of regulatory documents, including INDs, NDAs, briefing packets, Investigator Brochures, etc.
- Assist with the design, analysis, and interpretation of studies involving sparse sampling and provide guidance to optimize study designs
- Ph.D. in Biostatistics and 5 + years of relevant work experience, including FDA interactions
- Demonstrated understanding of statistical methods used in drug development
- Pharmaceutical/GMP experiences
- Ability to show critical thinking with logical problem-solving
- Statistical Programming Capability
- Excellent written and verbal communication skills
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AVROBIO, Inc is an EEO employer
AVROBIO, Inc., a leader in lentiviral-based gene therapies, is a clinical-stage company developing disruptive therapies that have the potential to transform patients’ lives with a single dose. The Company is focused on the development of its gene therapy candidate, AVR‑RD‑01, in Fabry disease, as well as additional gene therapy programs in other lysosomal storage disorders including Gaucher disease, Cystinosis and Pompe disease. AVROBIO’s lentiviral platform has broad potential for other rare and non-rare genetic diseases. AVROBIO is headquartered in Cambridge, MA and has offices in Toronto, ON.