SP (1-2 years experience)

Remote: 
Full Remote
Contract: 
Work from: 

Offer summary

Qualifications:

Educated to degree level in a relevant discipline or equivalent work experience., Excellent analytical skills and knowledge of programming and reporting processes., Familiarity with SOPs/Guidelines, ICH-GCP, and applicable regulations., Competent in written and oral English with good communication skills..

Key responsabilities:

  • Perform statistical programming for assigned projects, ensuring high quality and value.
  • Produce low-medium complexity derived datasets, tables, figures, and data listings.
  • Maintain documentation for studies to ensure regulatory compliance and traceability.
  • Participate in audits and inspections, ensuring adherence to SOPs and guidelines.

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Parexel XLarge http://www.parexel.com
10001 Employees
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Job description

When our values align, there's no limit to what we can achieve.
 
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.

Job Description

Key Accountabilities:

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 low-medium complexity derived datasets (e.g. SDTM, ADaM), tables, figures, and data listings.

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.

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.

Skills:

  • Excellent analytical skills.
  • 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.
  • 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.

Knowledge and Experience:

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


Education:

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

Required profile

Experience

Spoken language(s):
English
Check out the description to know which languages are mandatory.

Other Skills

  • Analytical Skills
  • Teamwork
  • Detail Oriented
  • Communication
  • Time Management

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