Statistician/Statistical Programmer, Nairobi

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Job Detail

  • Job ID 1006029
  • Career Level  Officer
  • Experience  5 Years
  • Industry  Development
  • Qualifications  Degree Bachelor

Job Description

Specific job responsibilities

  •  Contribute to the design of the study protocols including sample size estimation and power analysis.
  •  Perform random number generation and patient allocation for RCT.
  •  Develop Statistical Analysis Plans (SAP), TLF shell and dataset specifications for SDTM and ADaM.
  •  Be an SDTM and ADAM expert providing advice and training.
  •  Writing analysis programs to meet specifications of the SAP/lead statistical programming activities as trial programmer as well as making statistical programming decisions/recommendations at study/project level.
  •  Maintain proficiency in SAS and awareness of developments.
  •  Identify areas where new processes are required as well as create, review and update SOPs and Study Specific Procedures (SSPs).
  •  Analyzing and interpreting data from clinical trials and other studies.
  •  Liaise with the Senior Manager, Data Management and Biostatistics and coordinating office (Regional Operations Manager) to develop quarterly and yearly work-plans to determine activities and targets for the period.
  •  Identify and resolve data discrepancies in liaison with data managers.
  •  Participate in validation of Clinical Data Management Systems including edit check programs.
  •  Support study team in developing data collection tools and preparing data entry templates.
  •  Contribute to Case Report From (CRF) design and all other data management and statistical documentation.
  •  Perform additional management activities as required to provide timely and high-quality data for the purposes of analysis and/or regulatory submissions, database creation and testing.
  •  Maintain strict confidentiality of all privileged information regarding data and the organization.
  •  Assist in writing the statistical section of the CSR and ensure the CSR accurately describes the statistical methods and results of analyses.
  •  Ensure appropriate analysis procedures are used in statistical analyses.
  •  Create case report tabulations (CRT) from clinical trial data.
  •  Ability to work on multiple projects, plan, organize and prioritize activities.
  •  Be aware of up-and-coming changes to regulatory guidelines/requirements and awareness of emerging standards and associated impact to ongoing and future planned trials.
  •  Build and maintain effective working relationships with cross-functional teams.
  •  Comply with organization and industry standards (e.g. CDISC) and processes.
  •  Mentor other staff on statistical analysis/statistical programming.

Required skills

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