Senior Biostatistician
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Job Description
Senior Biostatistician for Therapeutics, Inc. managing statistical aspects of clinical trials in dermatology. Overseeing projects, statistical analysis, and ensuring quality results.
Responsibilities:
- Leadership and Project Management of statistical aspects of assigned project portfolio
- Oversight and development of statistical and programming techniques to ensure quality and on time delivery of generated results
- Contribute to the writing of statistical sections of study protocols
- Perform sample size calculation, develop randomization specifications
- Review and provide statistical input into the development of case report forms design
- Author Statistical Analysis Plans (SAPs)
- Research, development and application of statistical methodologies and processes
- Develop and/or review SDTM and ADaM dataset specifications
- Create table and listing shells per the SAP
- Generate database listings for QA audits
- Assist data management and trial management team in preparing for database lock
- Write and/or supervise SAS programming and QC to create SDTM and ADaM data sets
- Perform statistical analyses of data and interpret results
- Collaborate with medical writer in the production of integrated clinical study reports
- Contribute to the regulatory submissions including development of Integrated Summaries of Safety (ISS) and Efficacy (ISE)
- Interact with members of the Clinical Development Team
- Participate in Clinical Development Team meetings and client meetings
- Participate in departmental infrastructure building and maintain programming standards.
Requirements:
- Master’s or Doctoral level degree in statistics
- At least 5 years of experience performing statistical analysis and reporting for clinical trials
- Thorough understanding of GCPs, FDA and ICH guidelines
- Excellent problem solving, organizational, written and oral communication skills
- Ability to manage multiple priorities and attention to detail
- Strong computer proficiency and SAS programming skills
- Knowledge of core technical and regulatory requirements
- Sound experience in the design, analysis and reporting of clinical studies
- Strong communication, collaboration and team working skills.
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