The Statistical Programmer I works with supervision to support various programming activities related to the analysis and reporting of clinical study data.
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 low-medium complexity derived datasets (e.g. SDTM, ADaM), tables, figures, and data listings.
Maintain and expand local and international regulatory knowledge within the clinical industry.
Develop knowledge of SAS and processes / procedures within other Parexel functional areas. 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.
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
Demonstrated application of CRS concepts to achieve best practice and promote continuous improvement
Demonstrate ability to learn new systems and function in an evolving technical environment
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
Attention to detail.
Excellent analytical skills.
Good presentation skills.
Tenacity to work in an innovative environment.
Ability to negotiate and influence in order to achieve results.
Business / Operational skills that include customer focus, commitment to quality management and problem solving.
Good business awareness / business development skills (including financial awareness).
Ability to create, maintain and define strategies to improve the efficiency of running a clinical trial.
Work effectively in a quality-focused environment.
Demonstrate commitment to refine quality processes.
Effective time management in order to meet daily metrics or team objectives
Show commitment to and perform consistently high quality work
Educated to degree level in a relevant discipline and / or equivalent work experience
Competent in written and oral English.
Excellent communication skills.
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.
How can we help you on your journey? Find your path, and learn more on LinkedIn, YouTube, Facebook, Twitter, and Glassdoor.