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
Originally posted on Himalayas