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Principal Statistical Programmer

Software EngineerSoftware EngineerFull TimeRemoteLeadTeam 10,001+Since 1983H1B SponsorCompany SiteLinkedIn

Location

India

Posted

112 days ago

Salary

0

Seniority

Lead

Bachelor DegreeExperience acceptedEnglishGCP

Job Description

Principal Statistical Programmer

Parexel

• Ability to fill Statistical Programming Lead role on projects • 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 • Coordinate project start-up activities, creation of global programs, tracking spreadsheets, and other required documentation • Review statistical analysis plans and mock-shells • Review database set-up specifications • Provide leadership, project specific training, stakeholder management, external sponsor support, resource management, and project management for the required programming tasks supporting clinical trial activities • Interact with sponsors and internal stakeholders with regard to statistical programming issues • Assist project teams in the resolution of problems encountered in the conduct of their daily work • Deliver best value and high quality service • Check own work in an ongoing way to ensure first-time quality • Use efficient programming techniques to produce/QC derived datasets (e.g. SDTM, ADaM), tables, figures, and data listings • Produce/QC dataset specifications and other process supporting documents and submission documentation • Ensure quality control (QC) is performed on all process and technical activities related to derived dataset, table, data listing, and figure programming in accordance with corporate quality standards, SOPs/Guidelines, ICH-GCP, and/or other international regulatory requirements • Maintain and expand local and international regulatory knowledge within the clinical industry • Develop knowledge of areas of Clinical Data Management Systems (CDMS), Electronic Data Capture (EDC), Clinical Trial Management System (CTMS), Safety Reporting, SAS, and processes/procedures within other Parexel functional areas • Provide relevant training and mentorship to staff and project teams • Lead knowledge sharing forums and proactively support the development of the wider department • Maintain all supporting documentation for studies in accordance with SOPs/Guidelines to ensure traceability and regulatory compliance • Ensure compliance with SOPs/Guidelines, ICH-GCP, and any other applicable local and international regulations, and participate in internal/external audits and regulatory inspections as required • Proactively participate in and/or lead process/quality improvement initiatives • Provide consultancy to internal and external sponsors with regard to statistical programming tasks • Represent Parexel at sponsor marketing and technical meetings. • Assessment of technology and processes, to facilitate best practices and increase quality, efficiency, and productivity • Represent Statistical Programming on cross-functional technical initiatives • Understand regulatory requirements concerning industry technical standards (e.g. CDISC, 21 CFR Part 11, and electronic submissions)

Job Requirements

  • Educated to degree level in a relevant discipline and/or equivalent work experience
  • Competent in written and oral English
  • Excellent analytical skills
  • Advanced knowledge of SAS programming techniques
  • Extensive knowledge and understanding of the programming and reporting process
  • Good knowledge of SOPs/Guidelines, ICH-GCP, and any other applicable local and international regulations such as 21 CFR Part 11
  • Knowledge of the efficacy endpoints and analysis techniques specific to the disease being treated
  • Ability to learn new systems and function in an evolving technical environment
  • Strong project management skills
  • Strong organizational skills, ability to manage competing priorities, and flexibility to change.
  • Attention to detail.
  • Ability to successfully lead and mentor a global team
  • Excellent time management in order to meet daily metrics or team objectives.
  • Strong business/operational skills that include customer focus, commitment to quality management, and problem solving
  • Good presentation skills.
  • Ability to negotiate and influence in order to achieve results.
  • Good business awareness/business development skills (including financial awareness).

Benefits

  • Health insurance
  • Retirement plans
  • Paid time off
  • Professional development

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