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PAREXEL International LLC
Company Name
Parexel International India Private Limited
Bengaluru / Bangalore, Hyderabad / Secunderabad
6 - 9 years
Key Skills
Quality Control, Statistical Programming, Quality Management Groups, WSOP, Guidelines to ensure traceability and regulatory compliance
Other Roles
Posted On
14th Mar 2018
  PAREXEL International Corporation is a leading global bio/pharmaceutical services organization providing a broad range of knowledge-based contract research  
  Principal Statistical Programmer  
  Company profile | All Jobs by this Recruiter  

  • Deliver best value and high quality service
  • Ability to fill Statistical Programming Coordinator role on projects. The Statistical Programming
  • Coordinator will:
  • Input into and negotiate statistical programming timelines. Ensure that timelines are adhered to.
  • Coordinate and lead a statistical programming team to successful completion of a study within given timelines and budget
  • Monitor project resourcing, project budgets, and identify changes in scope
  • Interact with Sponsors as the key contact with regard to statistical programming issues
  • Provide technical support and advice to the internal team
  • Check own work in an ongoing way to ensure first-time quality
  • Ensure quality control (QC) on all process and technical activities related to derived dataset, table, listing, and figure programming in accordance with corporate quality standards, WSOPs/Guidelines, ICH-GCP and/or other international regulatory requirements are performed.
  • Coordinate project start-up activities, including Unix/PMED project area set-up, creation of global
  • programs (e.g.,,, etc.), tracking spreadsheets, and required documentation.
  • Assist in the production and QC of analysis plans, produce and QC TLF mock-shells, derived dataset specifications, programming specifications, and other process supporting documents.
  • Use efficient programming techniques to produce and/or QC derived datasets tables, figures and data listings.
  • Understand regulatory requirements concerning industry technical standards (e.g., CDISC, 21 CFR Part 11, electronic submissions, etc.) and implications for the department.
  • Provide input into monthly PERFORM forecasts and monitor the completion of forecasted units.
  • Create standard macros and applications to improve the efficiency of the department.
  • Maintain all supporting documentation for studies in accordance with WSOPs/Guidelines to ensure traceability and regulatory compliance
  • Be trained in sponsor WSOP’s and disseminate knowledge to project team members as appropriate.
  • Proactively participate in and/or lead process/quality improvement initiatives
  • Work closely with the Quality Management Groups (QMG) to ensure compliance with WSOPs/Guidelines, ICH-GCP and any other applicable local and international regulations and participate in internal/external audits and regulatory inspections as required
  • Develop wider knowledge of SAS and other relevant programming languages and processes within the GRO, Biostatistics, and Medical arenas.
  • Maintain and expand local and international regulatory knowledge within the clinical industry
  • Assist project teams in the resolution of problems encountered in the conduct of their daily work
  • Provide relevant training and mentorship to staff and project teams





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