• Job Description

  Req#: 27717401
  Work Location and Classification
  Remote - East Coast, USA
  
  Mission
  The Head of Biometrics will be an experienced, hands-on biostatistician who heads the Data Sciences group within the Clinical Development organization. This position will provide strategic and technical inputs and oversee the operational activities of biostatistics, statistical programming, and data management functions to support the company’s clinical development programs in gene therapies for retinal diseases.
  
  Reporting Relationship
  • This position reports to the Chief Medical Officer, or designee
  
  Duties and Responsibilities
  • Provide strategic and technical leadership across multiple phases of drug development including but not limited to study design/conduct/analysis, study result interpretations, regulatory interactions, publications, and clinical development planning.
  • Ensure high quality and effective conduct of biostatistics, statistical programming, and data management functions.
  • Manage and optimize resources (budgets, staffs, and technologies, etc.) to achieve business goals and objectives.
  • Provide organizational leadership to the Data Science group. Recruit (as needed), train and mentor staff.
  • Represent the company’s Data Sciences group, more specifically the Biostatistics function, to work with Health Authorities and Key Opinion Leaders as needed.
  • Collaborate with relevant functional areas to reach key R&D milestones.
  • Provide input to statistical analysis plans, the evaluation and interpretation of study results, as well as the preparation of statistical summary reports.
  • When necessary, step in as a project statistician to work with the cross-functional team to design and operationalize clinical trials; and be accountable/responsible for statistical deliverables such as inputs to study schema and other study documents (e.g., DSMC charters), sample size and power calculation, randomization schema, statistical analysis plans, table shells, and analysis outputs (e.g., TLFs), etc.
  • Lead the preparation of topline reports summarizing the results of milestone data analysis (e.g., interim, or final analysis). Work with cross-functional team to ensure an accurate interpretation of the data.
  • Perform or oversee the staff or vendors to perform data analyses to address ad-hoc questions in supporting various business needs.
  • Understand regulatory requirements related to the specific therapeutic areas and the implications for statistical methodology and analysis.
  • Provide strategic oversight with CROs in regard to data management and statistical activities, including identifying suitable partners, defining CRO responsibilities, and maintaining interactive management. • Work with relevant parties (e.g., IT) to standardize the key aspects (e.g., folder structures and access) of data repository in Data Sciences group.
  • Oversee development and maintenance of departmental SOPs.
  • As needed, provide statistical support for the design and analysis of nonclinical research and development studies and quality assurance programs.
  • Keep management abreast of issues and progress on projects.
  • Other duties as assigned.
  • This job description is subject to change at any time.
  
  Educational Qualifications
  • M.S. or PhD in statistics, biostatistics, or closely related fields
  • PhD preferred
  
  Additional Qualifications
  • At least fourteen (14) years of relevant experience in clinical development. Experience in ophthalmology and/or gene therapies is preferred.
  • CRO statistics vendor oversight experience.
  • Management experience.
  • Comprehensive knowledge of statistical methodologies used in clinical trials. Experience in adaptive designs and/or applications of real-world data is a plus.
  • Proficiency in statistical programming using SAS (and R a plus). Knowledge of other statistical and data management software packages is a plus.
  • Knowledge and experience with CDISC data standards and models.
  • Experience presenting statistical analysis plans to executive leadership and regulatory agencies.
  • Demonstrated in-depth understanding of GCP and FDA IND regulations (esp. the statistical guidelines) and experience in interacting with regulators.
  • Experience in NDA/BLA filings.
  • Understanding of FDA regulations in orphan diseases and/or regulations from agencies in other regions a plus.
  • Demonstrated ability to design and conduct statistical analyses in clinical development projects (in non-clinical research activities a plus).
  • Strong written and communication abilities and problem-solving skills.
  • Ability to effectively manage multiple tasks and projects.
  • Ability to be flexible and adapt to the changing needs of the organization.
  • Innate collaborative attitude, with demonstrated ability to work effectively in a small, fast-paced company environment.
  
  Physical Requirements
  • Physical demands:
  ☒ sedentary (<> ☐ light work (<> ☐ medium work (<> ☐ heavy work (<> ☐ very heavy work (> 100 lbs.)
  • Physical activity:
  ☒ repetitive motion
  ☐ balancing
  ☐ stooping
  ☐ lifting
  ☐ climbing
  ☐ kneeling/crouching
  ☐ crawling
  ☐ reaching
  ☐ standing
  ☒ typing/grasping
  ☐ walking
  ☐ pushing/pulling
  ☒ hearing
  • Visual acuity: reading, writing, preparing/analyzing data, transcribing
  • Working conditions: indoor office environment
  
  Supervisor Responsibilities
  • This position does require previous supervisory experience

• About the company

  With a highly specialized team of physicians and researchers, we use cutting-edge techniques to develop treatments for patients that have diseases caused by broken genes. We use gene therapy, which replaces those broken genes with normal functional gen...

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