We currently have an extremely exciting opportunity with a leading Biopharmaceutical company for a Statistical Programming Associate Director role working in their Respiratory and Immunology department.
This programming group has direct impact on their large-scale drug development and gives the chance for widespread patient impact. This role can be open to multiple east coast locations, and you will be a part of a global team which is driving innovation.
The candidate will lead and assist in programming activities for the analysis and reporting process, including Clinical study report development, regulatory submissions, scientific utilization of the data, and more.
You will be reporting to the Director of programming to lead, assist, and provide expertise in the following areas:
- Responsible for the delivery of the Clinical Study Report and Study/Analysis Data TFL’s.
- Provide statistical programming deliverables for regulatory submissions.
- Produce and maintain technical database standards.
- Develop Safety Update reports, benefit risk evaluations, and investigator reports.
- Plan and communicate the analysis of data to Safety monitoring boards and independent monitoring committees.
-BSc or higher is Statistical, Mathematical, Computer science, or Life Science related fields.
-Exceptional problem-solving skills and organization/attention to detail
-Extensive SAS experience within a Clinical Development or Healthcare organization at an advanced level
-Submission Experience along with Technical and regulatory expertise
-Extensive knowledge of CDISC standards
- Business Development Manager
Job location: Reading, Reading, England Job salary: £Salary Range : £70 – 85,000 PA + Benefits
My client is a Reading-based growing biotechn...
- Statistical Analyst I
Job location: Job salary: £Salary- $107,000-140,000
RBW is partnered with a full-service CRO look...
- Senior Biostatistician
Job location: Job salary: £Salary- $160,000-210,000
Looking for a change? We are partnered with a...