Junior Statistical SAS Programmer & Statistician

Job Description

Position:

Junior Statistical SAS Programmer & Statistician

Department:

Statistics & Data Management

Direct Manager:

Head of Statistics & Data Management

Location:

Prague Czech Republic

Employment Type:

Full time employment, office-based

 

Position Summary:

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
  • 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
  • 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

 

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

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