Biostatistician - Middle East

21-10-2020

Title: Biostatistician
Location: Middle-East

 Qualifications and Experience:

  • 2 years of related biostatistics experience in either a pharmaceutical or CRO environment or other relatable statistical experience
  • Master’s degree in Biostatistics, Statistics
  • Knowledge of ICH guidelines and regulatory requirements as they relate to biostatistics activities, SAS programming
  • Experience providing ability to explain complex statistical concepts to other project team members
  • CDISC SDTM and ADaM dataset mapping experience
  • Therapeutic experience in transplantation, autoimmune diseases, and kidney and liver disease

The main responsibilities:

  • Act as primary statistical contact for internal and external project team members.
  • Communicate and work with Biostatistics management to maintain the project budget and timelines.
  • Review case report forms (CRFs) and completion instructions
  • Give input to database design and data edit considerations necessary to collect and clean data
  • Develop, or assist in the development of, Interim Analysis Plans (IAPs) and Statistical Analysis Plans (SAPs) as needed per the protocol
  • Develop program specifications – SDTM and ADaM dataset specifications and mock tables, listings and figures (TLFs) – needed to perform the analysis defined in the IAP/SAP
  • Perform the statistical analysis by independently programming derived datasets and TLFs and validate the developer’s corresponding programs per department SOPs
  • Develop or review statistical methods and results sections of statistical reports, clinical study reports (CSRs), or publications
  • Assist in planning and designing clinical studies, including:
    • overall study design development
    • outcome / endpoint determination
    • power analysis / sample size estimation reports
    • randomization and blinding procedures development
    • statistical methods section development in the protocol
    • Develop, or assist in the development of, Randomization Plans and randomization programs or lists
  • Carry out all activities according to CTI SOPs and project-specific conventions within the framework of Good Clinical Practice (GCP) / International Conference on Harmonization (ICH) guidelines
  • Rely on instructions and Biostatistics SOPs to ensure timely, standard, and quality deliverables to customers
  • Maintains accurate records of all work performed and ensure all relevant statistics documents are filed in the eTMF per the project-specific eTMF Plan
  • Provide input to and participate in departmental meetings

 

 

If interested, please send your CV to jobs@clinart.net mentioning the Job Title in the subject

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