Hbus-co22-01 Director of Biostatistics

**_Opportunity to work at the cutting edge of drug development_**

Hummingbird Bioscience is an innovative clinical-stage biotech company focused on developing precision therapies against hard-to-drug targets to improve treatment outcomes. We harness the latest advances in systems biology and data science to better understand and solve the underlying causes of disease and guide development of our therapeutics.

Enabled by our proprietary Rational Antibody Discovery platform, we discover antibodies against optimal yet elusive epitopes on important targets that have not been successfully drugged, unlocking novel mechanisms of action.

We are advancing a rich pipeline of first

**About the Role**

Join Hummingbird Bioscience as we transition from an early-stage drug discovery company to a global leader in drug development. We are looking for a Director of Biostatistics who will influence and drive the statistical and data management strategy within the organization. This individual will be responsible for providing statistical input into the design of clinical/translational/preclinical studies, protocols, and statistical analysis plans, while also overseeing key quantitative scientific and data management functions including clinical pharmacology, statistical programming, and data management. The Director of Biostatistics will also have the opportunity to lay the foundation for Hummingbird’s data infrastructure for our clinical, translational, preclinical, and discovery studies.

**Responsibilities will include (but are not limited to)**:

- Provide scientifically rigorous statistical input into the company’s clinical development plans, dose-finding strategies, regulatory strategies, publications, as well as translational and preclinical/discovery projects as needed
- Oversee the development of the clinical/translational/preclinical data infrastructure within Hummingbird, in collaboration with the IT team and other stakeholders
- Oversee other related internal or external functions, including statistical programming, data management, and clinical pharmacology and develop of strategies and operating procedures for these functions
- Serve as the primary statistical author or reviewer of protocols, statistical analysis plans, clinical study reports and other projects as needed
- Collaborate closely with clinical science, regulatory and other functions to drive quantitative decision-making during drug development
- Ensure that all study and project level statistical activities are conducted in compliance with relevant regulatory requirements

**Core Experience and Qualifications**:

- Ph.D. in Statistics (or related field) plus minimum of 5-10 years experience in biotech/pharma, preferably in oncology
- Thorough understanding of statistical principles, clinical trial methodology and data management, including deep familiarity with CDISC standards
- Working knowledge of SAS
- Experience in PK/PD modelling and simulations
- Understanding of data management and statistical programming requirements
- Ability to develop innovative statistical/technical solutions to complex problems
- Understanding of the drug development process and guidelines from pre-IND through registration
- Knowledge and experience in meeting regulatory guidance, both FDA and international regulatory agencies
- Strong verbal and written communication skills including ability to explain methodology and consequences of decisions in lay terms
- Strong management skills
- Excellent interpersonal skills with the ability to build relationships across internal and external partners in a global environment
- Ability to work independently and with the flexibility to handle workflow in a fast-paced start-up environment
- Hummingbird Bioscience is firmly committed to Equal Employment Opportunity (EEO) and to compliance with all Singapore and US federal, state and local laws and/or guidelines that prohibit employment discrimination on the basis of age, race, color, gender, sexual orientation, gender identity, ethnicity, national origin, citizenship, religion, genetic carrier status, disability, pregnancy, childbirth or related medical conditions, marital status, protected veteran status and other protected classifications._