Statistical Programmer-II (FSP)
Hyderabad, India Job ID R0000021335 Category Statistical Programming Date Posted 11/19/2024Overview
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.
Success Profile
Do you have these soft skills and interpersonal traits to succeed at Parexel?
- Analytical
- Detail-oriented
- Independent
- Proactive
- Responsible
- Team-player
About This Role
Job Profile Summary
The Statistical Programmer II provides technical expertise for the conduct of clinical trials, and works with minimal supervision to support various programming activities related to the analysis and reporting of clinical study data. In addition, the Statistical Programmer II may fill the Statistical Programming Lead role (or part of that role) on small, non-complex projects.
Key Accountabilities:
Project Management:
- Assist in the coordination of project start-up activities, creation of global programs, tracking spreadsheets, and other required documentation.
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 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.
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 as appropriate.
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 process/quality improvement initiatives.
- Understand regulatory requirements concerning industry technical standards (e.g. CDISC, 21 CFR Part 11, and electronic submissions).
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.
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.
Potential Career Path
Parexel offers career paths for Statistical Programmers to progress in their technical position or managerial position, as well as options to move to other areas of the business.
- Statistical Programmer I
- Statistical Programmer II
- Senior Statistical Programmer
- Subject Matter ExpertPeople Management
Employee Insights
Why Statistical Programmers work at Parexel
