Axogen is looking to solve the business problem of restoring health and improving quality of life by making the restoration of peripheral nerve function an expected standard of care. They aim to lead the markets they serve by ensuring their solutions offer an improved benefit-to-risk profile compared to existing standards of care, guiding and expecting market and design requirement specifications for engineering, business development, and clinical research activities to objectively target advancements in standards of care.
Requirements
- Develop and/or review ADaM and/or SDTM dataset specifications.
- Perform statistical programming to either build analysis datasets and generate statistical tables, listings and graphs (TLGs) or perform QC validation of these datasets and TLGs.
- Perform complex statistical modeling and analyses, implement new statistical analysis methods and strategies.
- Perform statistical analysis as per SAP, and address peer/QC review comments and findings.
- Perform statistical validation of core results, address additional QC validation comments and findings on the core results.
- Provide statistical input to Case Report Forms (CRF) design and database/variable structure.
- Specify and/or program database quality acceptance checks, assess and report data quality issues, and follow through until resolution.
Responsibilities
- developing statistical analysis plans
- performing basic and complex statistical analysis
- interpretation and reporting of study results
- providing data analysis input to meet project objectives
- contributing to statistical analysis sections of IRB and grant applications
- developing and executing statistical programs to perform analyses and prepare data displays
- drafting analysis and results sections for clinical study reports and scientific papers
Other
- Demonstrated success in delivering on goals and being part of fast-moving, collaborative team
- Broad regulatory understanding of functions and processes involved in pharmaceutical, biologic, and/or medical device product development
- Must demonstrate strong interpersonal, written, and oral communication skills across various levels of management and demonstrate the ability to manage differences and needs between multiple stakeholders
- A Ph.D. degree or equivalent in statistical science, mathematical analysis or related field plus 5 years’ relevant experience or a master’s degree plus 8 years’ relevant experience with demonstrated ability and sustained performance at the Ph.D. level.
- Minimum 5 years of experience working in the biologic/biotechnology, pharmaceutical, and/or medical device industry
