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Statistician/Statistical Programmer, Nairobi

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Job Detail

  • Job ID 1005857
  • Career Level  Officer
  • Experience  5 Years
  • Industry  Development
  • Qualifications  Degree Bachelor

Job Description

Responsiilities

  • 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

accounting Excellent knowledge of and experience with CDISC standards (e.g., programming of SDTM and ADaM datas Knowledge in the creation of define.xml, Pinnacle 21, aDRG, and sDRG. Proficient SAS programming skills. Strong ability to use initiative, prioritize, multi-task, and work well under pressure to meet deadl

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