A well-known CRO company is looking for a Lead Statistician to lead all efforts on all phases of clinical trials. This candidate will be the point of contact on all sponsors and vendors and will apply knowledge of statistics and apply them to prepare statistical analysis plans. This candidate will also have the unique opportunity to work on NDA submissions.
This position is a fully remote opportunity
- Independently utilize your respected expertise to provide statistical consulting
- Prepare statistical sections of protocols, performing sample size and power calculation for studies
- Review protocols, case report forms (CRFs), data management plans, data specifications and other related study documents
- Develop statistical analysis plans (SAP) in accordance with the protocols
- Develop SAS programs to create derived variables and analysis data sets
- MS in Statistics with 5 years or Ph.D with 3 years of clinical trials
- Proven knowledge of CDISC standards
- Ability to effectively communicate with others on the project team and in the department; strong interpersonal communication skills
- Demonstrated experience speaking cross-functionally with knowledge of SAS and SDTM data sets.