Senior Statistical SAS Programmer & Statistician

Job Description

Position: Senior 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:

The senior statistician is expected to contribute to strategic decisions, drug development plans, trial designs as well as interaction with health authorities and related activities, with high level of independence. Responsible for statistical programming aspects of individual clinical trials as well as project level tasks as assigned by the Head of Department.

 

Key Activities and Responsibilities:

  • Be responsible for statistical programming tasks regarding the assigned clinical trials as well as at the project level. These tasks include: planning and 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
  • Be responsible for statistical 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 interim, exploratory and additional analyses, statistical monitoring and consultation during the running phase regarding operational aspects.
  • 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 development of programming environment, related SOPs/WIs and standards
  • Contribute to scientific discussions, clinical development plan, strategic planning, interaction with health authorities, decision making 
  • Provide input to internal processes, standards and standard operating procedure,
  • Set up of new projects, project management for setup of database and reporting of clinical trials
  • Project management for outsourced conduct and reporting of clinical trials.Provide input to data management, database programming, statistical programming  and operational aspects related to setup, conduct and reporting of clinical trials conducted by the Company.
  • 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
  • Ensure timeliness and adequate quality of assigned deliverables
  • Establish and maintain sound working relationships and effective communication with statisticians, data managers and other functions/departments internally as well as with external partners
  • Perform these tasks with a high level of independence

 

 

Competences, Skills and Qualification:

  • At least Masters Degree in Statistics/Mathematics/Computer Science (or equivalent degree)
  • At least 5 years experienced in a sponsor or CRO as a statistical programmer.
  • Demonstrated professional experience as a SAS Programmer (excellent knowledge of SAS software, preferably SAS base and advanced certification)
  • Knowledge and expertise in theoretical and applied statistics, knowledge of statistical software packages (SAS) and/or R©.
  • Profound experience in statistical reporting for clinical trials
  • Previous experience in a pharmaceutical industry and clinical trials
  • Previous experience in Oncology is a plus
  • Previous experience in a sponsor role, including a BLA/NDA development and submission is a plus
  • Knowledge of 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  excellent communication skills

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