Closing Date: 05 Apr 17
Type: Full Time
Salary (£): On Application
We are actively looking to hire a Senior Statistical Programmer to work in our offices based in Poland, Warsaw. We will consider some homeworking for experienced candidates in the Pharmaceutical Industry
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.We are actively looking to hire a Senior Statistical Programmer to work in our offices based in Poland, Warsaw. We will consider some homeworking for experienced candidates in the Pharmaceutical Industry- Deliver best value and high quality service- Ability to fill Statistical Programming Coordinator role on projects. The Statistical Programming Coordinator will:- 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- Interact with Sponsors as the key contact with regard to statistical programming issues- Provide technical support and advice to the internal team- Check own work in an ongoing way to ensure first-time quality- 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.- Coordinate 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 analysis plans, produce and QC TLF mock-shells, derived dataset specifications, programming specifications, and other process supporting documents.- Use efficient programming techniques to produce and/or QC derived datasets tables, figures and data listings.- Understand regulatory requirements concerning industry technical standards (e.g., CDISC, 21 CFR Part 11, electronic submissions, etc.) and implications for the department.- Provide input into monthly PERFORM forecasts and monitor the completion of forecasted units.- Create standard macros and applications to improve the efficiency of the department.- Maintain all supporting documentation for studies in accordance with WSOPs/Guidelines to ensure traceability and regulatory compliance- Be trained in sponsor WSOP's and disseminate knowledge to project team members as appropriate.- Proactively participate in and/or lead process/quality improvement initiatives- Work closely with the Quality Management Groups (QMG) to 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.- Maintain and expand local and international regulatory knowledge within the clinical industry- Assist project teams in the resolution of problems encountered in the conduct of their daily work- Provide relevant training and mentorship to staff and project teams- Proficiency in SAS- Knowledge of the programming and reporting process- Demonstrate ability to learn new systems and function in an evolving technical environment.- Strong leadership ability- 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- 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- Shows commitment to and performs consistently high quality workEducation- Educated to degree level in a relevant discipline and/or equivalent work experienceLanguage Skills- Competent in written and oral English and Polish- Excellent communication skills.Minimum Work Experience- Relevant Clinical Trial industry experience
101-105 Oxford Road
|Tel:||+44 1895 238000|
|Fax:||+44 1895 238494|
|Website:||Visit Our Web Site|
PharmiWeb.com is Europe's leading industry-sponsored portal for the Pharmaceutical sector, providing the latest jobs, news, features and events listings.
The information provided on PharmiWeb.com is designed to support, not replace, the relationship that exists between a patient/site visitor and his/her physician.