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Position Summary:
Provide statistical support for clinical trials in medical devices under the direct supervision of a senior biostatistician. Work as part of a multidisciplinary team to support product development activities while developing core biostatistics skills. .
General Responsibilities:
- Conduct data analysis for clinical trial publications under supervision and collaborate with internal and external partners
- Support and execute clinical trials activities for medical devices including:
- Clinical trial design and sample size calculations for Clinical Study Synopsis and Clinical Investigation Plans (protocols)
- Simulation programs to assess trial operating characteristics
- Input on effective data collection methods
- Randomization plans and lists
- Statistical Analysis Plans (SAPs) with appropriate methodology and data presentation
- Blind data review and unblinding processes
- Programming instructions to statistical programmers; review and approve programming deliverables
- Interpretation and communication of data and statistical results, including Clinical Study Report (CSR) development
- Contribute to real-world data analyses and meta-analyses
- Implement standard operating procedures and best practice documents for statistical approaches
- Review and apply new statistical methods to existing processes
- Ensure proper documentation of all activities (traceability, data specifications, analysis validation) per internal procedures
- Contribute to project management plans and meet deadlines
- Communicate statistical concepts and results clearly to non-statistical colleagues
- Apply critical thinking to evaluate data analysis results
- Perform other tasks as assigned by line management
Skills and Experience:
- Strong fundamentals in probability and inference.
- Hands-on experience with SAS and/or R.
- Good written and verbal communication skills.
- Organized, analytical, and able to follow documented procedures.
- Ability to explain statistical concepts to non-statistical audiences
Education:
- University degree (BSc or higher) in Statistics, Biostatistics, Mathematics, Epidemiology or related field.
Travel Requirements:
- Occasional travel may be required.
