Cook MyoSite, Inc. is on a mission to make regenerative medicine a part of everyday medicine. We’re investigating our core technology, autologous muscle-derived cells, for the potential treatment of several muscle-related disorders. We at Cook MyoSite have the potential to make a difference in the lives of countless people around the world, and we also have the potential to make a difference in yours. Joining our team is an opportunity to ignite your passion, grow your potential, and define your purpose. If you’re curious, motivated by helping others, and driven by integrity, we invite you to apply.
This position is responsible for providing statistical expertise to clinical development programs. The Biostatistician applies statistical methodology to ensure that the clinical trial designs, programming, and analyses are statistically valid and meet the recognized international standards.
• Support the statistical needs of global projects on behalf of the organization.
• Develop, test, and run SAS programs for the statistical analysis and reporting of clinical study data, including programs for derived datasets, CDISC (SDTM and ADaM) datasets, tables, figures and listings, and their validation.
• Apply statistical and research methodological principles to the design, execution, analysis, and interpretation of clinical trials as well as assist in defining the strategy for clinical trials.
• Ensure that the data and statistical activities comply with regulatory and company standards.
• Author and provide input on relevant sections of clinical research protocols along with the content and format of data collection activities.
• Author and provide input on the statistical analysis plans.
• Assist in the development of case report forms.
• Advise on safety monitoring of clinical studies, including the development of appropriate study monitoring criteria.
• Maintain familiarity with company statistical software and provide custom programming for data reporting and statistical analysis.
• Make statistical contributions to regulatory applications, clinical study reports, abstracts, and manuscripts for publication.
• Produce ad hoc data summaries.
• Provide statistical interpretation and explanation of results to team members.
• Work effectively with contract research organizations on biostatistics deliverables, including verification of tables, listings, and figures.
• Master’s degree in Statistics or Applied Mathematics is required; PhD preferred
• Minimum of 1-3 years' experience in Biostatistics
• Prior experience in the conduct of clinical studies and working knowledge of FDA and ICH regulatory requirements.
• Experience interacting with regulatory agencies, both US and ex-US.
• Remote / Field Based Settings: General office or home office setting.
• Ability to conduct and hear ordinary conversation and telephone communication.
• Must be able to work extended hours beyond normal work schedule to include, but not limited to, evenings, weekends, extended work hours and/or extra work hours, sometimes on short notice as required.
• Ability to work under specific time constraints.
• Must be able to sit at desk, in meetings and/or work on a computer for long or extended periods of time.
• Visual and manual acuity for working with computers and equipment.
• Must be (a) physically capable of operating a motor vehicle on a regular basis, (b) a holder of a valid driver's license, and (c) in good standing to legally operate a motor vehicle.
• Physically capable of standing, walking, stooping, kneeling, crouching, climbing steps and ladders, reaching, twisting and bending on occasion with or without reasonable accommodations.
• Must be able to lift/push/pull up to 25 pounds on an occasional basis with or without reasonable accommodations.