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Job Details

Statistical Programmers (Sr level) / Home Based - MASTER

Company: Docs Global (Continental Europe)
Location: Spain- any location,Spain
Reference: Ref AS-020447
Closing Date: 23 Nov 18
Type: Contract
Salary (£): Competitive
Benefits: Excellent & Comprehensive

Job Summary:

For candidates with the appropriate credentials and experience, there are opportunities to take on programming leadership roles at the Program and Trial-level, coordinating teams of programmers to deliver high-quality analyses to support product development and commercial objectives. This is an exciting opportunity for motivated, experienced Statistical Programmers to join one of the world’s largest providers of functional service solutions to the pharmaceutical...


Roles & Responsibilities of the position

As a Statistical Programmer in this new team you will be involved in one or more clinical development programs spanning all phases of Clinical Research and your assignments would involve:
• supporting Global Submissions to FDA, EMA and PMDA (and other regulatory authorities)
• supporting key pivotal trials in late development compounds
• creating integrated efficacy/safety summaries and other submission related documents
• preparing analyses to support preparations for Advisory committees (ODAC and AdCom)
• supporting HAQs as and when needed
All new trials are following CDISC standards and utilize cutting edge statistical reporting systems.

Job Requirements

- At least 5 years previous clinical programming experience fo. Mor
- Proven experience in development of advanced MACROs (such as MACROs to support analysis data set and TFL creation) with high programming efficiency.
- Working experience in pooling analysis datasets across multiple clinical studies (or equivalent).
- Demonstrated skills in developing data sets and TFLs in line with sponsor specifications.
- Working knowledge of database design/structures and basic statistics.
- Good understanding of regulatory requirements relevant to statistical programming (e.g. GCP, ICH).
- Strong knowledge of / experience with SAS and other relevant programming software.
- Working knowledge of CDISC data standards including ADaM and SDTM.
- Fluent English (oral and written).

All new trials are following CDISC standards and utilize cutting edge statistical reporting systems.

Remuneration & other details

- One of the most exciting R&D pipelines around
- A uniquely collegial working culture
- World-class research environment.
- Salary: Competitive.
- Home Office.
- Long term employment.

To apply:
Interested? Please submit your CV to or call +34 91 114 8290. We are looking forward to getting to know you.

Apply for this job: Statistical Programmers (Sr level) / Home Based - MASTER

Contact Information:

Address:  Head Office
2 Globeside, Globeside Business Park
Website:  Visit Our Web Site

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