Join Parexel as a Principal Statistical Programmer

At Parexel, aligning with our values is the key to limitless achievements. We share a unified goal: to enhance global health. From clinical trials to regulatory consulting and market access, our clinical development solutions are fueled by a profound conviction in our mission.

Why Parexel?

Every team member at Parexel, regardless of their role, contributes to the development of therapies that ultimately benefit patients. We approach our work with empathy, take it personally, and are committed to making a difference.

Key Responsibilities

Project Management

• Assume the role of Statistical Programming Lead on projects.
• Input and negotiate statistical programming timelines, ensuring adherence.
• Coordinate and lead a statistical programming team to achieve study completion within set timelines and budget.
• Monitor project resources, budgets, and identify scope changes.
• Ensure thorough documentation including creation of global programs and tracking spreadsheets.
• Review statistical analysis plans, mock shells, and database setup specifications.
• Provide leadership, project-specific training, stakeholder management, and sponsor support.
• Interact with sponsors and internal stakeholders to resolve statistical programming issues.

Statistical Programming for Assigned Projects

• Deliver best value and high-quality service consistently.
• Ensure first-time quality through ongoing self-review.
• Utilize efficient programming techniques for quality control (QC) of datasets, tables, figures, and listings.
• Produce and QC dataset specifications, supporting documents, and submission documentation.
• Adhere to corporate quality standards and international regulatory requirements including ICH-GCP.

Training & Development

• Expand and maintain regulatory knowledge within the clinical industry.
• Develop understanding of Clinical Data Management Systems, Electronic Data Capture, Safety Reporting, SAS, and related processes.
• Provide relevant training, mentorship, and lead knowledge-sharing forums.
• Support departmental development proactively.

General Functions

• Maintain all supporting documentation for studies to ensure compliance and traceability.
• Ensure adherence to SOPs/Guidelines and participate in audits and inspections.
• Lead quality/process improvement initiatives and consultancy tasks as needed.
• Represent Parexel at sponsor marketing and technical meetings.
• Assess technology and processes to optimize quality, efficiency, and productivity.
• Stay informed about regulatory requirements concerning industry technical standards.

Skills and Experience

• Excellent analytical skills with advanced knowledge of SAS programming.
• Thorough understanding of programming and reporting processes.
• Strong knowledge of SOPs/Guidelines and ICH-GCP regulations.
• Ability to manage multiple priorities with attention to detail and flexibility.
• Proven project management and team leadership skills in a global setting.
• Commitment to high-quality work and process improvement.
• Strong business skills including customer focus and problem-solving.
• Good presentation, negotiation, and influence skills for achieving results.
• Competence in written and oral English with excellent communication abilities.
• Record of successfully leading teams in a statistical programming environment.

Education

Educated to degree level in a relevant field or holding equivalent work experience.

About Parexel

Parexel is committed to improving global health. Join our mission-driven team and contribute to meaningful clinical development solutions.

Ready to make a difference? Apply now to become our Principal Statistical Programmer.