
Director, Biostatistics
Summit Therapeutics, Inc.
full-time
Posted on:
Location Type: Office
Location: Miami • Florida • 🇺🇸 United States
Visit company websiteSalary
💰 $192,000 - $239,000 per year
Job Level
Lead
Tech Stack
Google Cloud Platform
About the role
- Serves as the study-level biostatistician including reviewing protocol, conducting sample size calculations, developing statistical analysis plan, data presentation plan, and Data Monitoring Committee (DMC) charter
- Partners with cross-functional team members in ensuring accuracy/consistency of clinical data and exceptional delivery, interpretation of clinical results
- Assists in the development and review of regulatory submission documents
- Implements biostatistics department policies, standards, procedures, and work instructions
Requirements
- Ph.D. in Statistics, Biostatistics or equivalent area with 6+ years biopharmaceutical industry experience required
- MS degree in related discipline with extensive industry and leadership experience (8+ years) can be considered
- Strong proficiencies in software and other tools typically used by Biostatistics (e.g. SAS, R)
- Good understanding of clinical trial processes and statistical programming requirements
- Working knowledge of ICH, FDA and GCP regulations and guidelines
- Attention to detail, accuracy and confidentiality
- Clear and concise oral and written communication skills
- Must be able to effectively multi-task and manage time-sensitive and highly confidential documents
- Communicate effectively and articulate complex ideas in an easily understandable way
- Work in a fast-paced, demanding and collaborative environment
Benefits
- bonuses
- stock
- benefits
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
biostatisticssample size calculationsstatistical analysis plandata presentation planregulatory submission documentsstatistical programming
Soft skills
attention to detailaccuracyconfidentialityoral communicationwritten communicationmulti-taskingtime managementcollaboration
Certifications
Ph.D. in StatisticsPh.D. in BiostatisticsMS degree in related discipline