Director of Biostatistics

Leap Therapeutics is seeking motivated individuals with biostatistics experience to be part of a growing oncology company.  Successful candidates will work within a highly collaborative team environment to lead, develop and implement statistical solutions to optimally support one or multiple clinical programs or Research projects.

 

Director of Biostatistics

 

Director

Reports to the Senior Director 

The candidate must have prior experience managing global clinical studies, CROs and vendors, regulatory submissions and health authority interactions within a sponsor company.  They must have prior experience managing complex clinical projects and providing direction and oversight to study team.  A thorough understanding of FDA regulations, GCP and ICH, are required along with strong interpersonal and organization skills.  Attention to detail is imperative.

Responsibilities 

Responsible for leading, developing and implementing statistical solutions to optimally support one or multiple clinical programs or Research projects. The role will include leadership of key clinical trial statistician responsibilities as well as working closely with the Research group to design and execute the exploratory biomarker and bioinformatic analysis.

 

Specific responsibilities include:

  • Plays a statistical leadership role in the design, analysis and interpretation of clinical studies and in the development and review of the study synopsis, protocol, statistical analysis plan, clinical study report and other regulatory submission documents, ensuring accuracy and statistical validity.

 

  • Provides analytical oversight of statistical activities of external vendors to ensure timelines and quality of analysis data and statistical output. Reviews and approves key statistical vendor deliverables.

 

  • Anticipates and communicates internal and external resource and quality issues that may impact deliverables or timelines. Propose and implement solutions. Escalate issues to management as appropriate in a timely manner.

 

  • Drives adherence to organizational standards and regulatory guidelines (e.g. FDA, ICH, etc.).

 

  • Represents Biostatistics with external review boards/ethics committees, health authorities, external consultants and respond to questions.

 

  • Drives the Bioinformatics component using computation, statistics, good understanding of biological problems an in-depth knowledge of methods for the analysis of biomedical data.

 

  • Support biomarker profiling studies in clinical trials and research collaborations including the analytical design, data interpretation and communication of results to impact the translational strategy.

 

  • Provide statistical input to support precision medicine strategies including companion diagnostic development, identification of predictive and prognostic biomarkers and understanding drug MoA.

 

  • Explains statistical concepts in an easy understandable way to non-statisticians and provide adequate statistical justifications and interpretation of analysis results for actions/decisions/statements, when required. Interprets and translates computational results into biologically relevant conclusions and hypotheses. Discusses biological questions, problems and outcomes.

 

  • Monitors and contributes to industry advances in statistical methods and implement innovative approaches.

 

Education / Experience / Skills:

  • A PhD/Masters degree in Statistics, Biostatistics, Bioinformatics or Computational Biology.

  • 10 years of relevant experience within the pharmaceutical industry and a thorough understanding of the drug development process.

  • Fluent with statistical software including SAS and R.

  • Proven knowledge and expertise in statistics with its application to clinical trials and in developing computational solutions and methods for research.

  • Demonstrated ability of leading, prioritizing and contributing to multiple discipline teams. Ensure timelines and objectives are met.

  • Strong ability and experience in interpreting computational results and translating them into biological relevant conclusions and hypotheses.

  • Proven ability to oversee, manage and communicate effectively with research vendors/CROs, and consultants.

  • Proven ability to work collaboratively and perform high quality analyses in a timely manner. Excellent project management skills.

  • Ability to evaluate existing computational methods and serve as a knowledge resource to collaborators seeking advice for the best tool for a particular problem.

  • Ability to read, analyze and interpret complex technical documents, and to present complex issues in oral and written form.

  • Strong attention to detail and accuracy is a must.

  • Background in clinical data/oncology/immune-oncology, analysis of genomic data and computational biology a plus.

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