Job Title: Statistical Programming Lead (Clinical Trials)
Location: Remote
Department: Statistical Programming Group
About Parexel:
At Parexel, our mission is to accelerate the delivery of innovative therapies to market. As part of the Statistical Programming group, you will play a critical role in analyzing, summarizing, and graphically presenting clinical data to evaluate the safety and efficacy of clinical trials. Your attention to detail, commitment to quality, and effective communication will contribute to getting new treatments into the hands of patients faster. You will work in diverse therapeutic areas, handling a variety of data entries and endpoints, providing opportunities for growth and career development.
Success Profile:
At Parexel, we value team members who are:
Analytical: Ability to assess and solve complex problems.
Detail-oriented: Focused on precision and accuracy.
Independent: Self-sufficient with the ability to work autonomously.
Proactive: Anticipating and addressing needs ahead of time.
Responsible: Taking ownership of your work and outcomes.
Team-player: Collaborating effectively with colleagues to achieve shared goals.
Key Responsibilities:
Project Management:
Leadership: Lead the statistical programming team and oversee the successful completion of studies within set timelines and budget.
Timelines: Negotiate and ensure adherence to statistical programming timelines.
Coordination: Manage project start-up activities, create global programs, track project spreadsheets, and maintain necessary documentation.
Stakeholder Management: Communicate effectively with clients, Parexel teams, and other stakeholders regarding statistical programming tasks.
Issue Resolution: Assist in resolving challenges that arise during the project lifecycle.
Statistical Programming:
High-Quality Service: Deliver best value by producing high-quality datasets, tables, figures, and data listings (e.g., SDTM, ADaM).
Quality Control: Perform QC activities on all programming processes and documentation according to SOPs/Guidelines and regulatory standards.
Documentation: Create and manage dataset specifications and submission documentation.
Training and Mentorship:
Regulatory Knowledge: Maintain and expand your understanding of local and international clinical regulatory standards.
Mentoring: Provide training and mentorship to staff and project teams, and lead knowledge-sharing forums.
Process Improvement: Contribute to process/quality improvement initiatives within the statistical programming department.
General Responsibilities:
Compliance: Ensure adherence to SOPs, ICH-GCP, and local/international regulations, participating in audits as necessary.
Client Consultation: Provide expert advice to both internal and external sponsors on statistical programming tasks.
Cross-Functional Collaboration: Represent Statistical Programming in cross-functional projects and initiatives.
Regulatory Awareness: Stay informed on technical standards (e.g., CDISC, 21 CFR Part 11) and participate in electronic submissions.
Skills & Experience:
Programming Expertise: Advanced knowledge of SAS programming techniques and experience in statistical analysis and reporting.
Project Management: Strong project management, organizational skills, and the ability to manage competing priorities.
Analytical Thinking: Excellent analytical skills and attention to detail.
Communication: Strong written and oral communication skills, with the ability to present and negotiate effectively.
Regulatory Knowledge: Thorough understanding of SOPs, ICH-GCP, 21 CFR Part 11, and other relevant regulations.
Team Leadership: Proven experience in leading global teams in a statistical programming environment.
Client-Focused: Ability to engage and communicate effectively with clients and stakeholders.
Education:
Required: Degree in a relevant discipline (e.g., Statistics, Mathematics, Life Sciences), or equivalent work experience in statistical programming.
Why Parexel?
Parexel provides a fertile environment for growth, offering extensive training, mentoring, and technical knowledge sharing. We pride ourselves on fostering a supportive and motivating work environment that celebrates diversity and inclusion.
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