Senior Statistical Analyst Lead
2 weeks ago
The role of the Principal Biostatistician involves providing expert statistical support to various projects across the organization. This includes serving as a mentor to biostatisticians, overseeing training plans and materials, and directing the activities of other biostatistics personnel.
Key responsibilities include:
- Leading complex or multiple projects, such as submissions and integrated analyses, and attending regulatory agency meetings as needed.
- Preparing or overseeing the preparation of Statistical Analysis Plans (SAPs), including development of well-presented mock-up displays for tables, listings, and figures.
- Collaborating with sponsors on project-related matters.
- Managing scheduling and time constraints across multiple projects, setting goals based on priorities from management, and communicating proactively to biostatistics management any difficulties with meeting these timelines.
The ideal candidate will have previous experience in Medical Affairs and/or HEOR and HTA, a graduate degree in biostatistics or a related discipline, and extensive experience in clinical trials or an equivalent combination of education and experience.
Proficiency in programming and the ability to apply extensive knowledge of statistical design, analysis, relevant regulatory guidelines, and programming techniques utilized in clinical research are essential.
Excellent written and verbal communication skills are also required, along with the ability to read, write, speak, and understand English.
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