Manager overseeing Project Management team in Clinical Research at Sanford Health. Collaborating with Clinical Research Managers and guiding strategic research initiatives.
About the role
- Senior Biostatistician providing biostatistics support for clinical evidence generation strategies at Olympus. Overseeing clinical trials, leading statistical analysis, and collaborating with cross-functional teams.
Responsibilities
- Lead and oversee the design, implementation, and analysis of clinical trials for Olympus medical devices (i.e., conduct sample size and power analyses in support of proposal and protocol development).
- Conduct statistical analysis and interpretation of data to support decision making for clinical trial protocols.
- Collaborate with cross-functional teams (data management, study management, external vendors etc.) to ensure the quality and integrity of study data.
- Manage multiple research projects simultaneously, ensuring they are completed on time, within budget, and in compliance with regulatory guidelines.
- Develop statistical analysis plans and provide guidance on statistical methodologies.
- Lead the creation, standardization, and implementation of biostatistical tools, methodologies, SOPs, and best practices to ensure consistent, high-quality statistical support across clinical programs.
- Ensure compliance with regulatory requirements and guidelines in all statistical activities.
- Maintain accurate and organized documentation of all statistical analyses and results.
- Participate in the development of publications and presentations related to the clinical trial results.
- Identify and implement process improvements to increase efficiency and effectiveness in statistical analysis.
- Liaise with HEMA, Market intelligence, and other teams to ensure appropriate clinical evidence support and guidance to align in the development of Value Propositions by acting as a subject matter expert for biostatistics within the organization.
Requirements
- Bachelor or above degree in Biostatistics, Statistics, or a related quantitative field is required.
- Minimum of 6 years of experience in statistical analysis and data interpretation in the medical device or pharmaceutical industry.
- An understanding of medical device purchase decision-making in the US.
- Proficiency in a statistical programming package such as SAS or R.
- A strong work ethic to promote the development of life changing treatments for patients.
- Proven track record of designing and executing clinical trials and studies.
- Analytics skill set with experience in clinical studies or medical claims and other secondary data to generate patient safety, treatment efficacy and cost-effectiveness message is essential.
- Excellent communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams and present complex statistical findings to non-technical stakeholders.
- Ability to coordinate and manage multiple priorities in a changing environment with minimal supervision.
- Strong skills in data analysis and the effective presentation of results.
- Advanced computer skill proficiency in Excel and PowerPoint is necessary.
Benefits
- Competitive salaries, annual bonus and 401(k)* with company match
- Comprehensive medical, dental, vision coverage effective on start date
- 24/7 Employee Assistance Program
- Free live and on-demand Wellbeing Programs
- Generous Paid Vacation and Sick Time
- Paid Parental Leave and Adoption Assistance*
- 12 Paid Holidays
- On-Site Child Daycare, Café, Fitness Center**
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