As part of Parexel Consulting, you will create and maximize value for clients throughout the product lifecycle. You will be a strategic guide in getting products to market faster, smarter – and keeping them there –your scientific, technical, regulatory, and/or commercial expertise will put best practice standards to work for biopharmaceutical and medical device companies large and small.
In return, you will be provided with interesting opportunities for growth and development and exposed to a variety of challenging assignments, product types, geographic regions, and therapeutic areas. Plus, as member of Parexel Consulting, you will enjoy all the advantages of working remotely, combined with access to the mentorship from a team of highly experienced regulatory professionals at the height of their careers. Join our team, and you will design solutions for the complexities of an ever-changing global marketplace.
- Full Time
- Travel: Yes
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"When submitting major market applications, it’s key to ensure that the technical integrity of all data meets regulated requirement standards. Parexel makes this possible with a diverse team of seasoned professionals who care about getting important medicines to patients. This is Regulatory Operations at its best."Chris – Associate Director, Regulatory & Access
"In this role, I have had the unique opportunity to work with regulatory experts who are not only some of the most distinguished in their field, but are also some of the most compassionate people I know. I’ve been able to grow so much professionally by standing on the shoulders of giants!"Riley – Regulatory Affairs Consultant
We are one truly global team working together to propel each client´s journey ahead faster.
We value work-life balance. We try and keep regular hours and an emphasis on life outside the office.
Work with industry leaders and subject matter experts.
The ability to innovate, ask “what if” and try new solutions without fear of failure.
Opportunities to work on multiple accounts – never boring!
Strong management with depth of experience working for global health authorities.
Qualifications.The preferred candidate will have knowledge of SAS programming skills, however candidates without SAS knowledge but with knowledge of R or Python will also be considered. Candidates will need to have a programming background. Knowledge of SQL is needed. Applications from candidates with experience of working with Spotfire are encouraged. Candidates with experience of working with observational data and with epidemiological knowledge will be favoured. The main skills we are looking for however are the ability to interpret and clarify the details of a plan of analysis and to implement the programming necessary to deliver the results requested. Communication is key in this role.
Additional skills for a Senior Programmer
• 6 or more years programming at a Pharma company
• MSc required
• Working with large databases is essential
• Candidates would be expected to lead projects soon after starting
• Excellent analytical skills with sound Lead experience as a Statistical Programmer within the Clinical Research (CRO) environment is essential.
• Excellent analytical skills.
• Proficiency in SAS.
• Extensive knowledge and understanding of the programming and reporting process.
• Knowledge of SOP's/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.
Experience with real world healthcare data such as DRG, MarketScan, Optum, PharMetrics, Medicare and EMR databases.
• Educated to degree level in a relevant discipline and/or equivalent work experience.
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