Senior Statistical Programmer

2 weeks ago

Hyderabad, Telangana, India Parexel Full time ₹ 9,00,000 - ₹ 12,00,000 per year

Key Accountabilities:

Project Management

  • 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.
  • 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.

Statistical Programming for Assigned Projects

  • 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.

Training

  • Maintain and expand local and international regulatory knowledge within the clinical industry.
  • Develop knowledge of SAS and processes/procedures within other Parexel functional areas.
  • Provide relevant training and mentorship to staff and project teams.

General

  • 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.
  • Understand regulatory requirements concerning industry technical standards (e.g. CDISC, 21 CFR Part 11, and electronic submissions).

Skills:

  • Excellent analytical skills.
  • Proficiency in SAS.
  • Extensive knowledge and understanding of the programming and reporting process.
  • Knowledge of SOPs/Guidelines, ICH-GCP, and any other applicable local and international regulations such as 21 CFR Part 11.
  • 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 a global team.
  • Work effectively in a quality-focused environment.
  • Effective time management in order to meet daily metrics or team objectives.
  • Show commitment to and perform consistently high quality work.
  • Business/operational skills that include customer focus, commitment to quality management, and problem solving.
  • Demonstrate commitment to refine quality processes.
  • Good presentation skills.
  • Good business awareness/business development skills (including financial awareness).

Knowledge and Experience:

  • Competent in written and oral English.
  • Excellent communication skills.

Education:

  • Educated to degree level in a relevant discipline and/or equivalent work experience.

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