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As a member of Parexel’s Statistical Programming group, you analyze, summarize, and graphically present clinical data to assess the safety and efficacy of the clinical trial. It requires attention to detail, a commitment to quality, and effective communication to ensure new treatments reach patients faster. You will work in different therapeutic areas assessing a variety of data entries and endpoints in an ever-changing environment. We provide a fertile environment for growth, with extensive training, mentoring, and technical knowledge sharing. You will work closely with the client and Parexel teams and collaborate to maximize the collective strength. Experience a supportive and motivating work environment where our teams offer an inherent breadth of knowledge within a diverse and inclusive workplace.
Job Responsibility:
Analyze, summarize, and graphically present clinical data to assess the safety and efficacy of the clinical trial
Work in different therapeutic areas assessing a variety of data entries and endpoints in an ever-changing environment
Work closely with the client and Parexel teams and collaborate to maximize the collective strength
Requirements:
Ability to fill Statistical Programming Lead role on projects
Input into and negotiate statistical programming timelines
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
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
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
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)
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)
Competent in written and oral English
Excellent communication skills
Educated to degree level in a relevant discipline and/or equivalent work experience
Nice to have:
Analytical
Detail-oriented
Independent
Proactive
Responsible
Team-player
What we offer:
Extensive training, mentoring, and technical knowledge sharing