Senior Biostatistician - Federal Research Team
R
Rho IncClinical Research
United StatesFull-TimeSenior
Salary115000 - 135000 USD per year
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Job Details
- Experience
- 4-5 years
- Required Skills
- R
Requirements
- Master's or higher level degree in biostatistics, statistics, or a related field
- 4-5 years of experience conducting statistical analysis for clinical research projects
- Proficiency in SAS
- Strong written, verbal and presentation skills
- Attention to detail and understanding of high-quality scientific standards
- Honesty and integrity for collaborative culture
- Ability to think critically
- Agile and adaptable to change
- Proficiency in R (preferred for advanced methodologies)
Responsibilities
- Function as statistical lead on complex clinical trials, from development through closeout
- Design scientifically sound clinical research projects, demonstrating understanding of all key design components
- Author statistical sections of study documents (e.g. protocols and SAPs)
- Perform various types of statistical analyses of clinical research data
- Utilize statistical software programs (e.g., SAS, R) to implement advanced statistical methodologies
- Lead the creation of data documentation components of TMFs and regulatory submissions
- Investigate novel approaches for designing and analyzing clinical research projects and make strategic decisions
- Communicate analysis results and relevance to sponsor or investigators
- Ensure effective, accurate and timely communication of key issues and progress to the team and Sr. Management
- Exhibit the expertise to do tasks independently and to oversee, train and mentor others in task completion
- Participate in the Biostatistics community at Rho by contributing to internal initiatives and standard operating procedures
- Involvement with budgets, proposals, and other business development activities
- Create integrated databases for submission to regulatory bodies
- Represent sponsors at FDA meetings (type A, B, and C)
- Respond to information requests or other queries from regulatory bodies
- Author relevant sections of briefing books and briefing packages to support FDA interactions
- Advise and consult with sponsors regarding FDA data analytical and filing requirements
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