Experienced, creative, biostatistician to join our growing development team and lead the biostats support for Early Development candidates in Phase 1 and Phase 2 studies. In addition, to provide guidance and assistance to research and discovery colleagues on experimental design, data analyses and visualization.
- Assist research and development teams by providing analytical strategies with a focus on biostatistics and/or biology in major therapeutic areas and diseases;
- Develop statistical analysis plans to achieve study objectives for clinical trials;
- Identify, evaluate, refine and recommend statistical methods for use in analysis as appropriate ;
- Work effectively with biostatistics and data management CROs;
- Perform statistical analysis and programming (R, SAS, and other appropriate languages) in-house ,as needed;
- Provide quality control and statistical analysis of a wide spectrum of datasets (clinical safety and efficacy data, biomarker data, translational research data including biomarker data;
- Validate statistical results with team members to ensure high quality deliverables;
- Identify, interpret and present meaningful findings to key individuals (i.e. answer the “so what” questions) ;
- Have the ability to communicate complex analyses to varied audiences;
- Provide technical writing for analysis plans, protocols and regulatory documents as needed, and summarize results (i.e. tables, figures and listings) for inclusion in presentations or reports;
- Provide guidance to research and discovery colleagues on study design, data analyses, statistical methodologies with a focus on biostatistics, biology and programming
- Initiate building of in-house stats controlled environment (as needed) and data analysis archives.