We are looking for new talents that could fill the following roles:
Statistical Programmer: Junior and Senior
RequiredQualification and experience
University degree (or equivalent) in mathematics, statistics, informatics or related disciplines.
Good knowledge of programming languages and of data management principles and tools.
Experience in SAS programming within a pharmaceutical company
Experience working within a clinical research organization
Experience in programming including working within a pharmaceutical company or a clinical research organization.
Ability to communicate effectively in English.
Responsibilities and tasks
Responsible of implementation and use of programs able to effectively analyze and report clinical trial data.
Supports the implementation of computerized systems/tools that can facilitate the trials/projects data analysis, handling and flow, including the handling of organizational aspects.
Responsible of the definition of project and trial analysis databases. Informs and suggests solutions to the statistician on critical issues within the project.
Performs the programming for trial or project specific data reports and statistical evaluations in agreement with the guidelines of the statistician and/or the project statistical programmer, as appropriate, aimed to guarantee quality deliverables according to contractual obligations and ICH-GCP guidelines.
Discusses data presentation methods with the appropriate members of the project team.
Informs and suggests solutions to the biostatistics head on critical programming issues within the project.
Performs the programming for standard and special analyses and provides the appropriate members of the project team with trial or project specific listings, summary tabulations and graphics.
Maintains up-to-date documentation for the reporting, analysis and graphics software that is under his responsibility.
Provides technical advice and support to other project team members.
Assesses, recommends and develops new standards, policies and procedures.
Supports computerized systems/subsystems implementation that facilitate the handling and the documentation of trial specific or project specific CRF or non-CRF data, including data flow monitoring and reporting tools, according to the project quality requirements.
In agreement with the statistician and/or project statistical programmer, designs and implements trial and project analysis database structures and programs the algorithms that are to be applied to the data for the conversion between different database structures.
Statistician: Junior and Senior
Required Qualification and experience
University degree (or equivalent) in mathematics, statistics or related disciplines.
Good knowledge of statistical software (at least SAS®) and of data management principles and tools.
Experience in biometry department of pharmaceutical industry or clinical research organizations or University as statistician or PhD in Biostatistics.
Knowledge of international clinical research regulations and requirements.
Ability to manage international situations and to communicate clearly and effectively.
Responsibilities and tasks
Informs and suggests solutions to the statistics head on critical issues within the project.
Discusses protocol and CRF with the authors and members of the project team (when required).
Collaborates in the writing of the statistical section of the protocol (if asked to) stating the hypothesis, defining the planned analysis, primary and secondary variables, time periods, interim analysis specifications, intent-to-treat population and explaining the statistical basis for the choice of sample size.
Plans details of the randomization schedule with the appropriate members of the project team (if required).
Documents methods and procedures used in the analysis in a detailed SAP.
Plans and directs or performs the programming for the protocol specific data reports and statistical evaluations. Assists in programming and/or validation where appropriate.
Discusses and plans model reports, data presentation/statistical evaluation methods and writing responsibilities with the appropriate members of the project team.
Performs standard and special analyses and provides the appropriate members of the project team with listings, summary tabulations and graphics.
Participate in the writing of the statistical section/module of reports (FSR, integrated safety/efficacy reports and publications).
Maintains up-to-date project documentation including that of presentation, analysis and graphics software.
Verifies adherence to statistical standards and SOPs within the project.
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