Senior Statistical Programmer

India-Hyderabad-Remote

Parexel

For over 35 years Parexel has been a trusted global CRO and biopharmaceutical services company. Learn more about how we can help.

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When our values align, there's no limit to what we can achieve.
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At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

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:

  • Looking for 5+ Years of experience with statistical programming.
  • Development of the ADaM/TLF programming specification.
  • Experience working on the Statistical Analysis Plan.
  • Need to have experience on safety and efficacy analysis.
  • Expertise in clinical SAS/CDISC programming.
  • Creation and validation of ADaM datasets and TLFs.
  • Understands the project's timeframe and scope. Independently monitors and completes their own programming tasks.

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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* Salary range is an estimate based on our AI, ML, Data Science Salary Index πŸ’°

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Tags: CDISC Consulting GCP SAS Statistics

Perks/benefits: Career development

Regions: Remote/Anywhere Asia/Pacific
Country: India

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