Generate:Biomedicines is seeking a Director, Biostatistics to provide leadership and guidance as the statistical expert on a project team or within a therapeutic area to drive cross-functional alignment on statistical strategy.
Requirements
- PhD or equivalent degree in statistics/biostatistics with >8 years’ experience in the pharmaceutical industry, or MS degree in statistics/biostatistics with >10 years’ experience
- Expertise in statistical software such as R or SAS
- Deep knowledge of statistical methodologies for clinical trial designs, including adaptive, Bayesian, and platform trials, and analysis of various types of endpoints data
- Skilled in clinical trial simulations, including designing and interpreting complex simulation studies
- Prior statistical leadership or significant contribution to at least one late stage (Phase 2b and beyond) study
- Knowledge of drug discovery and development and ability to integrate statistical concepts into drug discovery and development strategies
- Capability to provide statistical leadership to cross-functional teams at the protocol and project level
Responsibilities
- Serve as a key statistical leader guiding clinical development strategies and regulatory submissions
- Analyze data and interpret results from clinical trials to meet the project objectives
- Apply and implement basic and complex statistical techniques independently to assigned projects
- Work with Statistical Programming to ensure programs meet analysis requirements, internal SOPs, and external regulatory requirements
- Oversee the activities of statistical service providers, as appropriate
- Identify the need for new process improvement initiatives, and lead working groups to solve the process gaps
- Identify the need for new statistical methodology and keep abreast of new developments in statistics, drug development, and regulatory guidance
Other
- Must be able to work productively in a fast-paced collaborative environment, with demonstrated critical thinking skills, time management skills, and effective communication skills
- Excellent verbal and written communication skills, and ability to clearly convey complex concepts and findings to both non-statistical and statistical audiences
- Driven for results with demonstrated interest and ability to welcome new challenges, embrace changes, take initiative, and find solutions to technical problems
- Demonstrated ability and interest to learn multiple disease indications, endpoints and appropriate statistical/regulatory requirements
- COVID-19 vaccination and booster required
- Commitment to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status
