Biostatistics support to late stage clinical trials for use in HTA dossiers

  • Belgium
  • from 501 / Day
  • 80 %
  • Expired
  • 566 days ago
  • 41

Domains of expertise

  • Data Management Stats
    • SAS Programmer
    • Statistician

Description

The services on this assignment will be in support of existing project teams delivering analysis and reporting on late stage projects for use in Health Technology Assessment Dossiers. The searched services will be in statistical programming using SAS on randomized clinical trials.

Specific requirements (skills) or experience for the assignment?

• Multiple years (preferably min 5) of relevant late stage clinical trial SAS statistical programming experience in analysis and reporting.
• Proficient SAS programming skills with mastery of SAS/STAT SAS/BASE, SAS macro language. SAS/GRAPH is a plus. SAS/MACRO is a must for this mission.
• Capacity to interface with clinicians and statisticians as statistical programmer in charge of a clinical trial.
• Capacity to work independently or under the guidance of a senior MSD statistical programmer.
• Capacity to quickly read SAS code (including MACRO code) developed by others, understand them in the context of clinical trials and adjust to address the business question.
• Knowledge and practice of CDISC SDTM and ADaM data standards. ADaM is a must have for this mission.
• Ability to work complying to the company programming SOPs, project data standards and macro library as well as capacity to develop project specific code independently under company SOPs.
• Strong and proven experience of work with clinical trial data in support of safety and efficacy analysis.
• Analyst: Able to contribute to the finalization of Programming Requirement Specifications based on study documents and minimal guidance from the programming and statistics project leads.
• Fast learner, team oriented, able to work independently.
• Able to read, write and speak fluently in English. English writing skills are a must for this mission.
• Experience with SAS on PC and UNIX platforms.

Skills required

  1. Candidates has to be motivated to do this job for 6 to 8 months;
  2. Candidates must be relocated to Belgium (so he/she has to be in the office at least 3days, 2 days from home is OK)
  3. Candidates with a notice period over 1.5 month, must NOT be presented because of the urgent of this mission
  4. Main responsibilities for this mission consists in updating existing ADaM analysis datasets (based on requirement from statistics) and identified key analysis programs (with creation of Tables, Figures, Listings and a related user guide) as well as developing new project specific AdaM analysis datasets and analysis programs. Proficient SAS programming skills with mastery of SAS/STAT SAS/BASE, SAS macro language. SAS/GRAPH is a nice to have. SAS/MACRO is a must for this mission. Capacity to interface with statisticians as statistical programmer in charge of a clinical trial. Team oriented person. Capacity to work independently or under the guidance of a senior MSD statistical programmer. Capacity to quickly read SAS code (including MACRO code) developed by others and understand them in the context of clinical trials. Knowledge and practice of CDISC SDTM and ADaM data standards. ADaM is a must have for this mission. Ability to work complying to the company programming SOPs, project data standards and macro library as well as capacity to develop project specific code independently under company SOPs. Strong and proven experience of work with late stage clinical trial data in support of safety and efficacy analysis. Oncology therapeutic area experience is an asset. Fast learner, team oriented, able to work independently. Able to read, write and speak fluently in English. English writing skills are a must for this mission. Experience with SAS on PC and UNIX platforms. Location: Services will be delivered in Brussels 
  • Company Type

    Recruitment company

  • Recruitment company recruiting on behalf of a

    Pharmaceutical/ Biotechnology company

  • Mission location(s)

    • Europe
      • Belgium
        • Brussels
        • Flanders region
          • Antwerp
          • East Flanders
          • Flemish Brabant
          • Limburg
          • West Flanders
        • Walloon region
          • Hainaut
          • Liège
          • Luxembourg
          • Namur
          • Walloon Brabant
    The Freelancer must resides in the same country as the mission's location
  • Mission start date

    As soon as possible

  • Education degree

    Master statistics

  • Experience level

    4 - 10 Years experience in this/these domain(s)

  • Fee proposed

    from 501 / Day (Euro)

  • Reference number

    180427-13130-CORTEX-52045
  • FTE Required

    80 %

  • Contract duration

    8 month(s)

  • Contract renewal?

    can be renewed