Junior Statistical SAS Programmer & Statistician - Accord Research
|Department:||Statistics & Data Management|
|Responsible To:||Head of Statistics & Data Management|
|Location:||Prague Czech Republic|
|Employment Type:||Full time employment, office-based|
Responsible for statistical programming and statistical aspects of individual clinical trials.
Key Activities and Responsibilities:
- Be responsible for statistical/programming tasks on the assigned clinical trials as well as on a project level. These tasks include: clinical trial design/planning, statistical analysis plan, reporting activities including exploratory analyses and additional analyses, statistical monitoring and consultation during the running phase, operational aspects.
- Contribute to statistical programming tasks regarding the assigned clinical trials as well as at the project level. These tasks include: production of datasets and TFLs, creating macros, validations, proper documentation, input to statistical analysis plan, operational aspects regarding producing the statistical reporting for clinical trials
- Ensure compliance with regulatory requirements, including appropriate reflection of guidelines regarding clinical trial analysis and reporting, implementation of standards such as CDISC, etc.
- Support and provide input to biostatistics, medical writing and data management as required
- Ensure timeliness and quality of assigned deliverables
- Establish and maintain sound working relationships and effective communication with other functions/departments
- Provide input to other study documents writing, i.e. protocol synopsis, protocol, clinical study report, etc.
- Provide input to all major project level documents such as summary documents, investigator brochure, DSUR, etc.
- Contribute to scientific discussions, interaction with health authorities, decision making
- Manage and supervise outsourcing of statistical and data management activities to CROs
- Provide input to data management, programming, and logistics
- Provide input to internal processes and standards
Competences, Skills and Qualification:
- At least Masters Degree in Statistics/Mathematics (or equivalent degree)
- Demonstrated professional experience as a SAS Programmer (operational knowledge of SAS software, with preferably SAS base and advanced certification)
- Experience in statistical reporting for clinical trials
- Previous experience in the pharmaceutical industry, i.e. sponsor or CRO is preferred
- Knowledge of basic statistical methods and data management
- Knowledge of regulatory guidelines, requirements, and standards (GCP, ICH, CDISC)
- Organized, with structured thinking and ability to understand complex data
- Fluent English and good communication skills
Contact us (email@example.com)
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