Deliver best value and high quality service
Ensure quality control (QC) on all process and technical activities related to derived dataset, table, listing, and figure programming in accordance with corporate quality standards, WSOPs / Guidelines, ICH-GCP and / or other international regulatory requirements are performed.
Assist in the coordination of project start-up activities, including Unix / PMED project area set-up, creation of global programs (e.
g., setup.sas, formats.sas, etc.), tracking spreadsheets, and required documentation.
Assist in the production and QC of derived dataset specifications, programming specifications, and other process supporting documents.
Use efficient programming techniques to produce derived datasets, tables, figures and data listings of any complexity and QC low-medium complexity derived datasets, tables, figures and data listings
Check own work in an ongoing way to ensure first-time quality.
Maintain all supporting documentation for studies in accordance with WSOPs / Guidelines to ensure traceability and regulatory compliance.
Proactively participate in quality improvement initiatives.
Ensure compliance with WSOPs / Guidelines, ICH-GCP and any other applicable local and international regulations and participate in internal / external audits and regulatory inspections as required
Develop wider knowledge of SAS and other relevant programming languages and processes within the GRO, Biostatistics, and Medical arenas.
Provide relevant training and mentorship to staff and project teams as appropriate.
Assist project teams in the resolution of problems encountered in the conduct of their daily work.
Proficiency in SAS.
Knowledge of the programming and reporting process
Knowledge of WSOPs / Guidelines / System Life Cycle methodologies, ICH-GCP and any other applicable local and international regulations such as 21 CFR Part 11 and proven practical application
Demonstrate ability to learn new systems and function in an evolving technical environment
Attention to detail
Ability to successfully work together with a ( virtual ) team (including international teams as required) as well as independently
Demonstrate strong organizational skills, ability to manage competing priorities, and be flexible to change
Business / Operational skills that include customer focus, commitment to quality management and problem solving
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
First degree (undergraduate or equivalent) in a relevant discipline is preferred or equivalent work experience
Competent in written English.
Good communication skills.
Minimum Work Experience
Relevant Clinical Trial industry experience
Why Work at Parexel
There are pivotal moments in every career : Sharing new treatments. Improving processes. Delivering life-saving advances.
The people who succeed are the ones who make the journey go further and faster every time. What if you had a partner to support you as you reach the next level in your professional path?
A partner who believes a collaborative environment is key to achieving your goals? A partner who is dedicated to your health and wellness so you can help make a difference in the lives of millions worldwide?
That’s PAREXEL. We’re a diverse team of professionals focused on one goal : getting treatments into the hands of those who need them most.
Working together, the results we bring to our clients and the opportunities we bring to our team get better with every step.