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Statistical Programmer II - FSP

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Parexel

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Location:
India , Hyderabad

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Category:
IT - Software Development

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Contract Type:
Not provided

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Salary:

Not provided
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Job Description:

As a member of Parexel’s Statistical Programming group, you analyze, summarize, and graphically present clinical data to assess the safety and efficacy of the clinical trial. It requires attention to detail, a commitment to quality, and effective communication to ensure new treatments reach patients faster. You will work in different therapeutic areas assessing a variety of data entries and endpoints in an ever-changing environment. We provide a fertile environment for growth, with extensive training, mentoring, and technical knowledge sharing. You will work closely with the client and Parexel teams and collaborate to maximize the collective strength. Experience a supportive and motivating work environment where our teams offer an inherent breadth of knowledge within a diverse and inclusive workplace.

Job Responsibility:

  • Assist in the coordination of project start-up activities, creation of global programs, tracking spreadsheets, and other required documentation
  • 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 derived datasets (e.g. SDTM, ADaM), tables, figures, and data listings of any complexity and QC low-medium complexity derived datasets, tables, figures, and data listings
  • Assist in the production/QC of derived dataset specifications and other process supporting documents and submission documentation
  • 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 as appropriate
  • 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 process/quality improvement initiatives
  • Understand regulatory requirements concerning industry technical standards (e.g. CDISC, 21 CFR Part 11, and electronic submissions)

Requirements:

  • Educated to degree level in a relevant discipline and/or equivalent work experience
  • Competent in written and oral English
  • Good communication skills
  • Excellent analytical skills
  • Proficiency in SAS
  • 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
  • Ability to manage competing priorities and flexibility to change
  • Attention to detail
  • Ability to successfully work as part of 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
What we offer:
  • Extensive training, mentoring, and technical knowledge sharing
  • Supportive and motivating work environment
  • Diverse and inclusive workplace
  • Opportunities for career growth
  • Flexible work arrangements
  • Diverse therapeutic areas and project exposure
  • Advanced Technology

Additional Information:

Job Posted:
January 11, 2026

Work Type:
Remote work
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