Description
This company specializes in multiple therapeutic areas including CNS, oncology and a few others. Their hopes are to hire a Senior Lead Statistical Programmer before the year's end or early next year to assist in the early phases of their ongoing clinical trials. The company culture is idea for someone who is interested in working at a mid-sized company that allows a lot of cross-functional work.The Senior Statistical Programmer serves as a lead programmer for assigned clinical/post-marketing study projects and is held accountable for all expected deliverables. The employee will work cross-functionally with biostatistics, data management, clinical and regulatory personnel and other departments as appropriate.
Core Responsibilities:
- Act as a lead programmer for assigned projects/studies.
- Understand and be accountable for project deliverables and attend project study team meetings
- Responsible for the development, validation, execution, maintenance, documentation, and archival of analysis datasets and programming code used in the analysis of clinical trial data targeted for regulatory submission.
- Review CRF, data management plan, statistical analysis plan, and other documents as appropriate (e.g. data transfer specifications with vendors)
- Review and provide feedback on data provided by vendors
- Develop analysis file specification and assign tasks to other programmers
- Track programming status, including verification status
- In accordance with departmental objectives, use and share prior experiences in solving complex problems in creative and effective ways.
- Plan, design, develop, implement, validate, and maintain software for the monitoring, reporting, and analysis of clinical trial data in accordance with department SOPs.
- Collaborate with statistician and assist in the development of the statistical analysis plan (SAP).
- Help develop and review case report forms and assist in the review of the clinical trial database system, structure, and validation.
- Develop project specific and departmental standardized programming tools and routines for analysis.
- Facilitate communication with and provide guidance to CROs/external vendors (data management CROs) to achieve defined objectives.
Position Requirements:
- 6+ years experience in Statistical Programming
- Masters in Statistics (preferred)
- Exceptional verbal and written communication
To find out more about Real please visit www.realstaffing.com