Job Title: Statistical Programmer (Clinical Trials)
Location: Remote
Department: Statistical Programming Group
About Parexel:
At Parexel, we focus on accelerating the delivery of innovative therapies to market. As a member of our Statistical Programming team, you will play a vital role in analyzing, summarizing, and presenting clinical trial data to assess safety and efficacy. This work is essential in ensuring new treatments reach patients faster. With a strong emphasis on detail, quality, and communication, you will work across different therapeutic areas, contributing to a diverse and ever-changing environment. We foster an atmosphere of growth with comprehensive training, mentoring, and technical knowledge sharing.
Success Profile:
To succeed at Parexel, you should possess the following traits:
Analytical: Strong problem-solving and analytical abilities.
Detail-oriented: Precision and accuracy in your work.
Independent: Capable of working autonomously and making decisions.
Proactive: Taking initiative and anticipating needs.
Responsible: Reliable and accountable for your work outcomes.
Team-player: Collaborative and cooperative with colleagues.
Key Responsibilities:
Project Management:
Assist with project start-up activities, creation of global programs, tracking spreadsheets, and other required documentation.
Coordinate the organization of project-related tasks to ensure smooth and timely completion.
Statistical Programming for Assigned Projects:
Deliver high-value, high-quality service in statistical programming.
Perform quality checks (QC) on derived datasets (e.g., SDTM, ADaM), tables, figures, and data listings, ensuring first-time quality.
Assist in the production and QC of derived dataset specifications and other supporting process documents for submissions.
Training:
Maintain and expand your knowledge of local and international regulatory standards.
Develop expertise in SAS and other relevant programming tools and processes.
Provide training and mentorship to staff and project teams as appropriate.
General Responsibilities:
Ensure compliance with SOPs/Guidelines, ICH-GCP, and applicable international regulations (e.g., 21 CFR Part 11).
Participate in internal and external audits and regulatory inspections as needed.
Proactively contribute to process and quality improvement initiatives.
Understand and apply regulatory requirements related to industry technical standards (e.g., CDISC, electronic submissions).
Skills and Experience:
Analytical Skills: Strong ability to analyze and interpret complex clinical data.
Proficiency in SAS: Essential for statistical programming and data analysis.
Knowledge of Programming and Reporting: Understanding of programming techniques and the overall reporting process.
Regulatory Knowledge: Familiarity with SOPs/Guidelines, ICH-GCP, and regulations such as 21 CFR Part 11.
Learning Agility: Ability to adapt to evolving technical environments and new systems.
Attention to Detail: Ensuring accuracy in all aspects of programming and data handling.
Team Collaboration: Ability to work effectively as part of a global team.
Time Management: Capable of managing competing priorities and meeting deadlines.
Customer-Focused: Commitment to providing high-quality service to clients.
Education and Qualifications:
Required: Degree in a relevant discipline (e.g., Statistics, Mathematics, Life Sciences), or equivalent work experience in statistical programming.
Why Parexel?
At Parexel, we provide an environment that supports professional growth, with extensive training, mentorship, and opportunities for career development. Our teams work together to share knowledge and achieve our mission of improving global health through innovation.
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