Senior Statistical Programmer
Parexel
India - Telangana - Hyderabad
2d ago

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.
  • Lead and supervise and / or create, implement and execute import and export programs, in either
  • standard format, client specific format or CDISC compliant format depending on nature of

    request.

  • Develop mapping specifications for data exports in accordance with applicable standards.
  • Qualifications

  • Proficiency in SAS.
  • Knowledge of the programming and reporting process.
  • Knowledge of WSOPs / Guidelines / System Life Cycle methodologies, ICH-GCP and any other
  • applicable local and international regulations such as 21 CFR Part 11 and proven practical

    application.

  • Demonstrate ability to learn new systems and function in an evolving technical environment.
  • Strong leadership ability.
  • Attention to detail.
  • Ability to successfully work together with a ( virtual ) team (including international teams as required) as well as independently.
  • Demonstrate strong organizational skills, ability to manage competing priorities, and be flexible to change.
  • Business / Operational skills that include customer focus, commitment to quality management and problem solving.
  • Good business awareness / business development skills (including financial awareness).
  • Ability to create, maintain and define strategies to improve the efficiency of running a clinical trial.
  • Work effectively in a quality-focused environment.
  • Demonstrate commitment to refine quality processes.
  • Effective time management in order to meet daily metrics or team objectives.
  • Shows commitment to and performs consistently high quality work.
  • Competent in written English.
  • Good communication skills.
  • Apply
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