A global research consulting group providing 360° support & services across all facets of clinical outcomes research.
Senior/Principal Statistical Programmer FSP
Location
Poland
Posted
58 days ago
Salary
0
Seniority
Senior
Job Description
Senior/Principal Statistical Programmer FSP
Clinical Outcomes Solutions
• Working fully embedded within one of our pharmaceutical clients, with the support of Cytel right behind you. • The Principal Statistical Programmer works independently with only concept level instruction and very little supervision, tracks progress, and provides expert technical support to team members. • Responsible for implementing all reporting and analysis activities for the Sponsor clinical trials. • Participate in overseeing CRO programmers to ensure that data summaries are delivered in a consistent, high-quality manner.
Job Requirements
- At a minimum bachelor’s degree in computer science, data science, mathematics, or statistics major preferred
- 7+ years of experience as a Statistical Programmer on a Biotech/Pharma Clinical Development Biometrics Team or with a similar team and experience supporting drug development, medical device development, or intervention studies
- Exceptional SAS programming skills and expertise in the development and implementation of statistical programming procedures and processes in a clinical development environment
- Extensive applied experience of CDISC standards (SDTM, ADaM, and Define.xml), medical terminology, clinical trial methodologies, and FDA/ICH regulation
- Experience supporting regulatory submissions, interacting with the FDA and/or global regulatory authorities
- Must be able to work independently
- Outstanding communication skills (written and verbal) and strong leadership skills.
Benefits
- Our commitment to developing our staff is only surpassed by our commitment to advancing treatment options available to patients.
- We work hard to create successful careers with significant professional growth for our employees and as a result work hard to make Cytel successful.
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