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Principal Statistical Programmer

Keywords / Skills : Quality Control, Statistical Programming, Quality Management Groups, WSOP, Guidelines to ensure traceability and regulatory compliance

6 - 9 years
Posted: 2018-04-05

Nationality
India
Role
Other Roles
Education
B.Pharm, B.Sc, M.Pharm, M.Sc, Other
Stream:
• Pharmacy
• Bio-Chemistry/Bio-Technology
• Biology
• Botany
• Chemistry
• Statistics
• Pharmacy
• Bio-Chemistry/Bio-Technology
• Biology
• Botany
• Chemistry
• Statistics
• Other
Posted On
5th Apr 2018
Job Description
  • 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., setup.sas, formats.sas, 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


About Company

PAREXEL International is a growing, fast-paced, global Clinical Research Organization (CRO) that has helped bring to market 49 of the top 50 selling pharmaceuticals. In fact, we have worked with all 10 of the world's top 10 pharmaceutical companies.

Given our breadth of expertise and the trust placed in us by major pharmaceutical companies worldwide, PAREXEL can provide you with a number of career options in Clinical Research that can rarely be found within just one company. In fact, over 25% of the positions opened at PAREXEL are filled by current employees working to advance their skills and careers.
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