Chinook Therapeutics is a biotechnology company developing precision medicines for patients with kidney diseases. We apply our proprietary research platform to discover and develop therapeutics with novel mechanisms of action against key kidney disease pathways. The development focus is on rare, serious disorders with clear unmet medical needs and with defined and rapid clinical development opportunities. Chinook’s pipeline currently has several internal programs at the validation and lead optimization stages rapidly progressing to enter clinical trials by 2021. We are also evaluating business development opportunities for early and late-stage clinical assets to enhance the pipeline.
Chinook has raised a $65 million Series A financing from top tier venture capital firms Versant Ventures, Apple Tree Partners, and Samsara BioCapital. We are a growing team of approximately 25 employees and are based in Vancouver, British Columbia and Seattle, Washington.
Reporting to the Chief Medical Officer, the Head of Biometrics will be responsible for providing strategic leadership and tactical oversight for Biostatistics and Statistical Programming across all programs in both early and late stage clinical development. This individual must have the ability to work in a fast-paced, team-oriented, start-up environment to execute on Chinook’s clinical development plans and corporate objectives.
- Establish and lead a high-performing biometrics team to support clinical development with a focus on quality, innovation, and excellence
- As a member of the Development leadership team, support strategic discussion and decision-making for product development
- Provide expert statistical review and guidance for the design and conduct of clinical studies and the analysis and interpretation of results
- Apply innovative approaches to study design and analysis
- Hire, develop and retain key talent by managing and mentoring biostatisticians, statistical programmers, and other team members as needed
- Oversee all biometrics activities including timely and high-quality study reporting while ensuring compliance with health authority regulations
- Represent Chinook in meetings with FDA or other regulatory agencies to discuss statistical issues to enhance the success of NDA and other submissions
- Author relevant sections and support review/finalization of clinical-regulatory documents
- Evaluate and manage CROs and/or other external resources, as needed to support biometrics activities
- Contribute to the development and maintenance of a positive team-focused company culture
Education, Experience, and Skills:
- PhD or MS in Biostatistics or related field
- Minimum of 10 years of experience in pharma or biotech
- Extensive knowledge and expertise in statistics and statistical programming and its application to clinical trials in early and late stage development
- Advanced knowledge of statistical programming languages (including SAS), software, and clinical database management
- Knowledge of FDA, EMA, ICH guidelines and regulations related to clinical trials, statistics, and data handling
- Prior experience as a significant contributor to NDA and/or other regulatory submissions
- Proven track record of effective leadership with experience managing direct reports, teams, and process development/improvement initiatives
- Experience overseeing biometrics activities/services provided by CROs and contractors
- Strong written and oral communication skills with an ability to communicate complex statistical and trial issues to Development Leadership Team to enable decision-making
Chinook is an Equal Opportunity Employer and we do not discriminate against any employee or applicant for employment because of race, color, sex, age, place of origin, religion, family status, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state, provincial or local protected ground.