Associate Director Biostatistics

*Role can based at our Cambridge, MA or Toronto, Ontario locations.  The role can also be remote in the U.S. or Canada.

We are looking for an Associate Director, Biostatistics who is passionate about their profession and inspired by being part of a clinical team, working in life sciences, to bring truly transformative gene 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, the Associate Director, Biostatistics will be working with clinical study teams on one or multiple projects within AVROBIO’s pipeline to facilitate in the design and conduct of clinical trials or registry studies; the evaluation, interpretation, and reporting of trial and registry results for regulatory submissions and publications. The Associate Director, Biostatistics will further be responsible to provide expertise in the implementation and development of statistical methodology for data analysis of investigator sponsored and in-house clinical trials to ensure the accuracy and reproducibility of data sets and analyses of clinical trial or registry data by following relevant work practices and procedures. The Associate Director, Biostatistics will communicate with clinical study teams regarding the study execution as it relates to timelines, data quality, and interpretation of results. In addition, the Associate Director, Biostatistics will provide statistical support to AVROBIO’s pre-clinical studies, in house clinical assay development, and to Quality and Manufacturing functional groups. 

Key Responsibilities

• Ensure all statistical work is processed on time to appropriate quality levels
• Possesses an advanced understanding of modern drug discovery and development processes
• Represents Biostatistics as a member of clinical trial teams, providing strategic input and technical guidance to team members, including sample size calculations or simulations
• 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.
• Develops statistical analysis plans for clinical trials or registry studies with fully documented table, listing, and figure shells
• Represent organization as the primary statistical contact on projects
• Review or 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
• Discuss statistical aspects of studies with medical director and regulatory authorities
• Liaises with medical writers, interpreting statistical results for input into clinical study report or other documents
• Supplies statistical input for regulatory submissions and in response to health authority questions
• Assist with in-house clinical assay validation
• Assist with statistical guidance and analysis the planning, conduct and interpretation of pre-clinical studies

Minimum Requirements/ Qualifications

• Ph.D. in Biostatistics and 5 + years of relevant work experience
• Experience in the design, execution, analysis and interpretation of clinical and preclinical trials
• Expertise and good understanding of statistical methods applied in drug development
• Pharmaceutical/GMP experiences
• Experience in submissions and interacting with regulatory bodies
• Experience in statistical assay validation
• Ability to show critical thinking with logical problem-solving
• Excellent influencing skills, which are applied effectively at all levels of an organization and across multiple functions
• Excellent written and verbal communication skills
• Self-motivated, independent worker
• Strong time management skills; able to effectively organize and manage a variety of tasks across different projects

About AVROBIO

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.

AVROBIO, Inc is an EEO employer