[Hiring] Principal Statistical Programmer @Parexel

Role Description

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

Key Accountabilities:

• Project Management
  • Ability to fill Statistical Programming Lead role on projects.
  • Input into and negotiate statistical programming timelines. Ensure that timelines are adhered to.
  • Coordinate and lead a statistical programming team to successful completion of a study within given timelines and budget.
  • Monitor project resourcing, project budgets, and identify changes in scope.
  • Coordinate project start-up activities, creation of global programs, tracking spreadsheets, and other required documentation.
  • Review statistical analysis plans and mock-shells.
  • Review database set-up specifications.
  • Provide leadership, project specific training, stakeholder management, external sponsor support, resource management, and project management for the required programming tasks supporting clinical trial activities.
  • Interact with sponsors and internal stakeholders with regard to statistical programming issues.
  • Assist project teams in the resolution of problems encountered in the conduct of their daily work.
• 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/QC derived datasets (e.g. SDTM, ADaM), tables, figures, and data listings.
  • Produce/QC dataset specifications and other process supporting documents and submission documentation.
  • Ensure quality control (QC) is performed on all process and technical activities related to derived dataset, table, data listing, and figure programming in accordance with corporate quality standards, SOPs/Guidelines, ICH-GCP, and/or other international regulatory requirements.
• 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.
  • Lead knowledge sharing forums and proactively support the development of the wider department.
• 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 and/or lead process/quality improvement initiatives.
  • Provide consultancy to internal and external sponsors with regard to statistical programming tasks.
  • Represent Parexel at sponsor marketing and technical meetings.
  • Assessment of technology and processes, to facilitate best practices and increase quality, efficiency, and productivity.
  • Represent Statistical Programming on cross-functional technical initiatives.
  • Understand regulatory requirements concerning industry technical standards (e.g. CDISC, 21 CFR Part 11, and electronic submissions).

Qualifications

• Excellent analytical skills.
• Advanced knowledge of SAS programming techniques.
• Extensive knowledge and understanding of the programming and reporting process.
• Good knowledge of SOPs/Guidelines, ICH-GCP, and any other applicable local and international regulations such as 21 CFR Part 11.
• Knowledge of the efficacy endpoints and analysis techniques specific to the disease being treated.
• Ability to learn new systems and function in an evolving technical environment.
• Strong project management skills.
• Strong organizational skills, ability to manage competing priorities, and flexibility to change.
• Attention to detail.
• Ability to successfully lead and mentor a global team.
• Work effectively in a quality-focused environment.
• Excellent time management in order to meet daily metrics or team objectives.
• Show commitment to and perform consistently high quality work.
• Strong business/operational skills that include customer focus, commitment to quality management, and problem solving.
• Demonstrate commitment to refine quality processes.
• Good presentation skills.
• Ability to negotiate and influence in order to achieve results.
• Good business awareness/business development skills (including financial awareness).
• Client-focused approach to work.
• Good negotiation skills.

Knowledge and Experience

• Competent in written and oral English.
• Excellent communication skills.
• Proven record of successfully leading teams in a statistical programming environment.

Education

• Educated to degree level in a relevant discipline and/or equivalent work experience.