At least a Bachelor’s degree (or equivalent) in mathematics, statistics, or related disciplines.
Good knowledge of statistical software (at least SAS® or R).
At least 5 years of experience in the biometry department of the pharmaceutical industry or clinical research organizations or University as a statistician in Biostatistics.
At least 2 years of experience in SAS.
Knowledge of CDISC standards (SDTM, ADaM).
Knowledge of international clinical research regulations and requirements.
Ability to manage international situations, liaise with sponsors and external stakeholders, and communicate clearly and effectively.
English language fluent.
Excellent planning, organizational skills, and attention to detail.
Inform and suggest solutions to the statistics head on critical issues within the project.
Discuss protocol and CRF with the authors and members of the project team (when required).
Collaborate in the writing of the statistical section of the protocol (if asked to) stating the hypothesis, defining the planned analysis, primary and secondary endpoints, time periods, interim analysis specifications, intent-to-treat population and explaining the statistical basis for the choice of sample size.
Plan details of the randomization schedule with the appropriate members of the project team (if required).
Document methods and procedures used in the analysis in a detailed SAP.
Plan and direct or perform the programming for the protocol specific data report and statistical evaluations. Assist in programming and/or validation where appropriate.
Discuss and plan model reports, data presentation/statistical evaluation methods and writing responsibilities with the appropriate members of the project team.
Perform standard and special analyses and provide 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).
Maintain up-to-date project documentation including presentation, analysis and graphics software.
Verify adherence to statistical standards and SOPs within the project.
Provide technical advice and support to other project team (statistician in particular) members.
Assess, recommend and develop new standards, policies and procedures.
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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.
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.
