Principal Statistical Programmer

When our values align theres no limit to what we can achieve.

At Parexel we all share the same goal - to improve the worlds 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 were 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).

Skills:

• 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.