Senior 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 startup activities creation of global programs tracking spreadsheets and other required documentation.

• Review statistical analysis plans and mockshells.

• Review database setup specifications.

• 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 firsttime 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 ICHGCP 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.

General:

• Maintain all supporting documentation for studies in accordance with SOPs/Guidelines to ensure traceability and regulatory compliance.

• Ensure compliance with SOPs/Guidelines ICHGCP 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.

• Understand regulatory requirements concerning industry technical standards(e.g. CDISC 21 CFR Part 11 and electronic submissions).

Skills:

• Excellent analytical skills.

• Proficiency in SAS.

• Extensive knowledge and understanding of the programming and reporting process.

• Knowledge of SOPs/Guidelines ICHGCP and any other applicable local and international regulations such as 21 CFR Part 11.

• 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 a global team.

• Work effectively in a qualityfocused environment.

• Effective time management in order to meet daily metrics or team objectives.

• Show commitment to and perform consistently high quality work.

• Business/operational skills that include customer focus commitment to quality management and problem solving.

• Demonstrate commitment to refine quality processes.

• Good presentation skills.

• Good business awareness/business development skills (including financial awareness).

Knowledge and Experience:

• Competent in written and oral English.

• Excellent communication skills.

Education:

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