IT Infrastructure Analyst focusing on server management and data extraction for cost reduction. Engaging with users for requirement gathering and supporting BI tools.
About the role
- Principal Statistical Analyst at Summit Therapeutics conducting statistical programming for oncology trials. Responsible for data analysis, compliance checks, and project management involving statistical activities.
Responsibilities
- Responsible for supporting and/or leading the statistical programming activities for clinical trial data collection, analysis, reporting, visualization on all Summit drugs
- Produce, review program codes and suggest alternative solutions that may be efficient
- Allocate resource for project, manage project timeline, control quality of deliverables and ensure compliance of procedure
- Work closely with Biostatistics to implement statistical analysis of clinical trial data
- Consolidate heterogeneous data source to prepare analysis-ready datasets supporting a particular project
- Perform compliance check and resolve any compliance issue during the process
- Create documentation for regulatory filings including reviewers guides and data definition documents
- Perform data analysis, statistical analysis, generate safety and efficacy tables, figures, and listings using SAS
Requirements
- Bachelor's or Master's degree in Biostatistics, statistics, computer science or related field
- Minimum 7+ years Pharmaceutical/Biotech programming experience
- Experience working with Oncology trials preferred
- Solid knowledge on CDISC standards including (SDTM, ADaM)
- Good understanding and hands on experience on programming support for data monitoring and data clean/query process
- Good understanding on clinical data coding dictionaries (MedDRA and WHODD)
- High degree of technical competence and communication ability, both oral and written
- Competent in SAS programming and Macro development
- Working knowledge of current regulatory requirements and ICH guidance
- Knowledge of Pinnacle 21
- Pharmaceutical experience with clinical trials, including NDA/BLA or other regulatory filling experience
Benefits
- Bonuses
- Stock options
- Benefits
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