Category

Description

Specific Tasks Would Include

• • Maintains the full-scope of responsibility for assigned projects: ensures on-time delivery, communicates the status of projects to internal teams and project Sponsors, executes quality assurance procedures on work produced by others and ensures statistical analysis is being done according to specifications.
  • Serves as lead statistician for assigned projects, coordinates and monitors work assignment of other supporting Biostatisticians and programmers.
  • Creates/maintains analyses, tables/listings/figures,
  • Writes/Reviews Statistical Analysis Plan (including Mock tables/listings).
  • Reviews Case Report Forms for assigned projects to ensure data is collected appropriately to achieve the analysis defined in the protocol.
  • Ensures table, listing and statistical analysis programming is being done according to Sponsor specifications (where not defined, within company standards).
  • Creates/QC specifications for, and programs, derived data sets.
  • Performs programming validation and ensures all Quality Control efforts have been followed.
  • Assists in writing and/or reviewing Statistical Reports.
  • Reviews protocol, providing feedback as well as adding to the methods section and providing input on project design issues, endpoint definition and sample sizes.
  • Provides sample size calculation and documentation.
  • Generates Randomization Schedules.
  • Works closely with Sponsor to ensure a high quality, timely delivery of tables/listings/figures and statistical reports.
  • Represents Biostatistics in communication with Sponsors.
  • Bibliography research for statistical analysis techniques.

Qualifications

• Master's degree or equivalent in statistics, mathematics or related field of project and some related experience or equivalent combination of education and experience.
• Working knowledge of GCPs, ICH guidelines, FDA and other applicable country regulations.
• Basic proficiency in BASE SAS, or other statistical software is advantageous, but not required.
• Understands the sequence of running programs to ensure up-to-date data and to troubleshoot, debug programming problems and to identify data trends.
• Nonverbal symbolism experience (formulas, scientific equations, graphs, musical notes, etc.,) in its most difficult phases.
• Good proficiency in Microsoft Word, Excel, and PowerPoint, Access.
• Effective verbal and writing skills; English local language, if relevant.

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