Principal Scientist responsible for drug discovery activities within Small Molecule Research at Novo Nordisk. Leading assay development, managing CROs, and collaborating across teams globally.
About the role
- Statistical lead developing biostatistical support for drug and vaccine projects in R&D. Interacting with multiple disciplines to ensure effective clinical trial design and analysis.
Responsibilities
- Serves as a statistical lead in project teams.
- Lead, develops, coordinates, and provides biostatistical support for related drug/vaccine projects in Late Development Statistics.
- Lead the interaction with Clinical, Regulatory, Statistical Programming, Data Management, and other Scientists from our Research & Development Division in designing and analyzing clinical trials, and in coordinating the statistical activities for clinical drug/vaccine projects.
- Independently identifies and anticipates technical or other potential problems arising in the design, conduct, and analysis of clinical trials, proposes solutions and carries them out.
- Develops individual protocols and data analysis plans and independently determines appropriate statistical methodology for analysis.
- Analyzes data and interprets results from clinical trials to meet objectives of the study protocol.
- Prepares oral and written reports to communicate results of clinical trials to the project team, our Company Management, regulatory agencies, or individual investigators.
Requirements
- PhD or equivalent degree in statistics/biostatistics or related discipline with a minimum of 9 years relevant work experience, or a Master’s degree with a minimum of 12 years relevant work experience.
- Solid knowledge of statistical analysis methodologies and experimental design.
- Strong scientific leadership in design and analysis of clinical trials.
- Strong project management skills.
- Solid knowledge of statistical and data processing software e.g. SAS and/or R.
- Solid understanding of worldwide regulatory requirements and clinical trial expertise from phase II to V.
- Excellent oral and written communication skills and strong leadership in a team environment.
- Demonstrated ability in statistical research activities and in application of novel methods to clinical trial development.
- Publications in peer reviewed statistical/medical journals.
Benefits
- medical, dental, vision healthcare and other insurance benefits (for employee and family)
- retirement benefits, including 401(k)
- paid holidays
- vacation
- compassionate and sick days
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