Jobs at PAREXEL

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• As an Enterprise Analytics & Intelligence Specialist and Power BI / Spotfire expert, contribute to the implementation of the Business Intelligence infrastructure at Parexel.  

Key Accountabilities:

• Develop and maintain Power BI / Spotfire dashboards and reports
• Design and implement data models to support the reporting
• Analyze data to identify trends and patterns
• Create and maintain data models
• Collaborate with stakeholders / customers to understand business requirements and develop solutions
• Validate the business needs with proof-of-concept prototypes
• Troubleshoot and debug reporting issues
• Monitor and optimize reporting performance
• Create necessary documentation required for dashboards
• Train Parexel personnel to apply and understand dashboards
• Support different project initiatives as assigned
• Understand and leverage global Corporate Quality/OED organization
• Anticipate potential organizational and cultural barriers to success and identify how to turn them into enablers

Skills:

• Understanding of Lean Six Sigma, Process Excellence, or similar methodologies

• Ability to learn and understand the business to support the development of solutions that are low maintenance and provide high value
• Computer literacy and expertise with MS Word, Excel, PowerPoint, Access, Business Objects Reports, SharePoint, HTML, TIBCO Spotfire or PowerBI (or equivalent)
• Understanding standards for data models, data warehouse and reporting performance-tuning techniques.
• Exhibits competency across core project management activities, including a strong focus on key performance indicators.
• Excellent presentation skills – ability to present effectively to technical and non-technical colleagues at all levels
• Positive attitude and ability to adjust to changing priorities, time zones, work assignments, unforeseen events, and new learning
• Culturally aware and ability to think and work with virtual/global teams and travel as needed
• Excellent listening skills, ability to build cross-functional relationships and influence without authority across all levels and functions to gain trust, and a client-focused approach to work
• Highly motivated, deliver work on time with high level of quality, ability to work with minimal supervision
• Exhibits a sense of urgency about solving problems and completing work
• Excellent interpersonal, verbal, written communication and decision-making skills, business understanding, and strong organizational skills
• Must be proficient in Agile methodology
• Ability to manage multiple, varied tasks with enthusiasm, and prioritize workload with attention to detail
• Willingness to work in a matrix environment and to value the importance of teamwork
• Excellent English written and oral communication skills

Knowledge and Experience:

• Computer Science with 3+ years of experience in data analysis, data visualization, and data modeling
• Proficiency in Power BI / Spotfire, SQL, and other data analysis tools
• Strong understanding of cloud computing and Microsoft Azure
• Experience developing custom business solutions
• Good understanding of technology & analytical skills as it relates to clinical trial activities, data warehouses, and applicable GCP regulations pertaining to computer systems

Education:

• Degree in Computer Science or equivalent with 3+ years of experience
• Business Intelligence and/or Statistical Data Analysis experience preferred

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Position Overview

• The Statistical Programmer II provides technical expertise for the conduct of clinical trials, and works with minimal supervision to support various programming activities related to the analysis and reporting of clinical study data. In addition, the Statistical Programmer II may fill the Statistical Programming Lead role (or part of that role) on small, non-complex projects.

Essential Skills and Experience Required:

• Excellent analytical skills.
• Proficiency in SAS (Minimum 18months experience and pref within clinical environment). Experience with SDTM, ADaM & CDISC.
• 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.
• Ability to manage competing priorities and flexibility to change.
• Attention to detail.
• Ability to successfully work as part of 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.
• Competent in written and oral English.
• Good communication skills.

Education Requirements:

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

Key Accountabilities of the Role:
Project Management:

• Assist in the coordination of project start-up activities, creation of global programs, tracking spreadsheets, and other required documentation.

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 derived datasets (e.g. SDTM, ADaM), tables, figures, and data listings of any complexity and QC low-medium complexity derived datasets, tables, figures, and data listings.
• Assist in the production/QC of derived dataset specifications and other process supporting documents and submission documentation.

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 as appropriate.

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 process/quality improvement initiatives.
• Understand regulatory requirements concerning industry technical standards (e.g. CDISC, 21 CFR Part 11, and electronic submissions).

go to method of application »

Overview of this Role:

• The Senior Statistical Programmer provides technical expertise for the conduct of clinical trials, acts as an internal subject matter expert in specific areas providing technical support and expert advice, and works independently to support various programing activities related to the analysis and reporting of clinical study data. In addition, the Senior Statistical Programmer can fill the Statistical Programming Lead role on projects, and liaise with sponsors, Biostatistics Leads, Data Management Leads, and other functional areas as required. Further, the Senior Statistical Programmer will monitor quality, timelines, resource allocation, and productivity in relation to budgets.

Experience, Knowledge and Skills Required for this Role:

• Excellent analytical skills.
• Proficiency in SAS with sound clinical SAS programming experience (min 18+ months experience within CRO). Sound ADaM, SDTM & CDISC skills.
• 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.

Education Requirements:

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

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).