Director, BiostatisticsShare to LinkedIn Apply Now Apply Now
Leap Therapeutics (Nasdaq: LPTX) is focused on developing targeted and immuno-oncology therapeutics. Leap’s most advanced clinical candidate, DKN-01, is a humanized monoclonal antibody targeting the Dickkopf-1 (DKK1) protein. DKN-01 is being developed in patients with esophagogastric, gynecologic, and colorectal cancers. FL-301, is a humanized monoclonal antibody targeting Claudin18.2, being developed in patients with gastric and pancreatic cancer. Leap also has preclinical antibody programs targeting Claudin18.2/CD137 and GDF15. For more information about Leap Therapeutics, please visit http://www.leaptx.com.
The Director, Biostatistics reports to the VP, Biomedical Operations and Head of Biometrics and serves as lead statistician in oncology cross-functional project teams. This role provides statistical support and leadership in strategic planning and execution for product development and regulatory submissions in oncology.
- Lead biostatistics in early and late clinical development planning to ensure that study designs are consistent with program objectives and meet worldwide regulatory and marketing needs.
- Develops individual protocols, statistical analysis plans, and determines appropriate statistical methodology for analysis.
- Develops and reviews clinical study reports, scientific publications and submission documents to ensure accuracy of the statistical content.
- Analyzes data and interprets results from clinical trials to meet objectives of the study protocol. Independently applies and implements basic and complex statistical techniques to these analyses.
- Provides responses to queries relating to study design, analysis, and interpretation posed by the clinical monitors, regulatory agencies, and/or investigators.
- Independently identifies and anticipates technical or other potential problems arising in the design, conduct, and analysis of clinical trials, proposes solutions and carries them out.
- Prepares oral and written reports to effectively communicate results of clinical trials to the project team, company management, regulatory agencies, or individual investigators.
- Interacts with Contract Research Organization (CRO) and external biometrics consultants to ensure deliverable timeline and quality.
- Lead research activities for innovative statistical methods and applications in clinical trial development.
- Evaluates appropriateness of available software for planned analyses and ascertains needs for potential program development of novel statistical methodology.
Education/ Experience/ Skills
- PhD or equivalent degree in statistics\biostatistics or related discipline.
- 6+ years of experience in the pharmaceutical or biotech industry.
- Solid knowledge of statistical analysis methodologies and experimental design.
- Strong scientific leadership and hands-on experiences in design and analysis of oncology clinical trials.
- Solid knowledge and experiences with statistical and analysis software, e.g., SAS and R.
- Solid knowledge of worldwide regulatory requirements and clinical trial expertise.
- Prior NDA/BLA submission experience in oncology.
- Excellent oral and written communication skills. Team player and experience to work successfully across functions.
- Demonstrated ability in statistical research activities and in application of novel methods to clinical trial development.
- Publications in peer reviewed statistical/medical journals.
- Must also demonstrate the ability to learn, be proactive and motivated, and consistently focus on details and execution.
Leap is an equal opportunity employer and extends equal opportunity to all individuals, without regard to race, color, creed, ancestry, national origin, citizenship, sex or gender (including pregnancy, childbirth, and pregnancy-related conditions), gender identity or expression (including transgender status), sexual orientation, marital status, religion, age, disability, genetic disposition, caregiver status, reproductive health decisions, status as a victim of domestic violence, sexual violence or stalking, credit history, criminal history, service in the military, or any other characteristic protected by applicable federal, state, or local laws and ordinances. We are committed to creating and maintaining a workplace in which all employees have an opportunity to participate and contribute to the success of the business and are valued for their skills, experience, and unique perspectives.