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4000 to 4500 per month
November 18 2017
- Collaborating in the process of protocol development by choosing an appropriate study design, including statistical methodologies, calculating necessary sample size to achieve a pre-specified power, and writing the statistical section of the protocol.
- Ensuring the correctness of the study assumption based on the sample size calculations which may be required by some literature search.
- Writing and reviewing Statistical Analysis Plans (SAPs) based on the protocol, including the development of well-presented mock-up displays for tables, listings, and figures. Collaborates with the sponsor.
- Directing the activities of other Biostatistics personnel on assigned projects to ensure timely completion of high quality work.
- Providing an independent review of the project work produced by other statisticians in the department.
- Participating in project teams as Biostatistics representative, interfacing as necessary with other departmental project team representatives.
- Supporting business development activities by contributing to proposals, budgets, and attending sponsor bid defense meetings.
- Creating or reviewing programming specifications for analysis datasets, tables, listings, and figures.
- Participating in Data Safety Monitoring Board and Data Monitoring Committee activities, including charter development and serving as an independent non-voting statistician.
- Conducting and participating in review and quality control of project deliverables, ensuring that output meets expectations and is consistent with analysis described in SAP.
- Discussing time estimates for completion of study-related activities with the Lead Statistician or Biostatistics management and proactively communicate to the Lead Statistician or Biostatistics management any difficulties with meeting these timelines.
- Monitoring progress on study activities against agreed upon milestones and ensures the study timelines for project deliverables are met.
- Identifying out of scope tasks and escalating those scopes to the management.
- Ensuring the proper study closeout by documenting and archiving study related materials according to Standard Operating Procedures (SOPs), and sponsor instructions.
- Generating and reviewing randomization schedule(s) to ensure there is no errors present and sponsor and protocol requirements are met.
- Performing ongoing monitoring of actual randomization scheme applied by IVRS/IWRS.
- Displaying a willingness to work with others and assist with projects and business unit initiatives as necessary to meet the needs of the business.
- An MSc or Ph.D. in Statistics or Medical Statistics
- Extensive experience in clinical trials and the drug development process within a CRO and Pharmaceutical environment preferably.
- Excellent project leadership experience with strong SAS experience.
- Ability to apply knowledge of statistical design, analysis and programming techniques used in clinical trials.