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Clinical Development Director
2 weeks ago
Senior Biostatistician Lead
Job Description:As a Senior Biostatistician, you will lead clinical development programs by understanding patient and business needs. You will develop or assist in the development of protocol designs, clinical plans, and data analysis plans in collaboration with physicians, clinical research scientists, and/or medical colleagues.
Key Responsibilities:
- Collaborate with study personnel to provide input on study protocol, design studies, and write protocols for each study's conduct.
- Assist in or be accountable for selecting statistical methods for data analysis, authoring corresponding sections of the protocol and the statistical analysis plan, and conducting actual analysis once a reporting database is created.
- Collaborate with data sciences in planning and implementing data quality assurance plans.
- Maintain currency with respect to statistical methodology, maintain proficiency in applying new and varied methods, and be competent in justifying methods selected.
- Perform peer-review of work products from other statistical colleagues.
Results Communication:
- Collaborate with team members to write reports and communicate results.
- Assist with, or be responsible for, communicating study results via regulatory submissions, manuscripts, or oral presentations in group settings, as well as one-on-one communication with key customers and presentations at scientific meetings.
Therapeutic Area Knowledge:
- Understand disease states, competitive landscapes, and regulatory environment to enhance customer focus and collaboration and be seen as a strong scientific contributor.
Regulatory Compliance:
- Work in full compliance with assigned curriculum(s) and follow applicable Corporate, Medical, local, and departmental policies, procedures, processes, and training.
Leadership and Teamwork:
- Introduce and apply innovative methodology and tools to solve critical problems.
- Merge scientific thinking and business knowledge to identify issues, evaluate options, and implement solutions.
- Lead projects independently and effectively across functions, applying technical expertise to influence business decisions.
