Senior Statistical Programmer

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.
• •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.

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.
• •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, ICH-GCP, 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 quality-focused 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.