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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