The Cytel blog keeps you up to speed with the latest developments in biostatistics and clinical biometrics.
Cytel has industry-leading experts in Statistical Programming with years of SAS® Programming expertise and in-depth knowledge of the specific clinical subject matter. Their insights into strategy, and high competence in project management ensure a new twist on the traditional CRO.
In February 2020 we interviewed Marc Lefebvre-Gouy who is a lead statistical programmer at Cytel in France. Marc made a career transition from genetics to statistical programming and in this interview, he speaks to us about programmers working across therapeutic areas, programming challenges across phases of a trial, and the top technical competencies every programmer must have. He also gives us a sneak peek of his hobby of cooking and his love for wine.
On March 16, the World Health Organization (WHO) Director-General, Dr. Tedros Adhanom Ghebreyesus, in his media briefing on COVID-19, described the coronavirus pandemic as “the defining global health crisis of our time". The pandemic has affected 176 countries and territories around the world. WHO is urging all governments to scale-up aggressive measures to combat COVID-19 as more cases and deaths are being reported across the globe. Until a vaccine is made available, social distancing is of the utmost importance to reduce transmission and enable health systems to cope.
The U.S. Centers for Disease Control and Prevention (CDC) defines social distancing as “remaining out of congregate settings, avoiding mass gatherings, and maintaining distance (approximately 6 feet or 2 meters) from others when possible” . Governments in several countries have shut down public places such as parks, gyms, malls, schools, restaurants etc., for a minimum of 15 days, to be extended depending upon the situation.
In these circumstances, it is inevitable that companies worldwide also show solidarity by allowing their employees to work remotely, from the safety of their homes. In Seattle, the hub of many of America’s early COVID-19 cases, companies including Amazon, LinkedIn, Microsoft and Google advised workers to stop coming to office in late February . With more employers taking this necessary and precautionary step, the question arises - how do we ensure that it is done right?
With only two weeks left for this fabulous year to end, we would like to thank all our blog subscribers and new readers for following and appreciating the Cytel blog. This year, we collaborated with several experts from both within and outside the company to bring to you a range of interesting topics including real-world evidence, AI, challenges in rare diseases, patient-reported outcomes, data management, and our popular series “The Good Data Submission Doctor” and “Career Perspectives”. In this blog, we share with you the top 5 Cytel blogs that resonated most with our community in 2019.
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PhUSE EU Connect 2019 was held in the beautiful city of Amsterdam between the 10th and 13th of November. This clinical data science conference comprised 19 Streams, including 150 papers, 24 posters and 3 engaging data scientists as keynote speakers. The event was well attended and had several interesting and innovative presentations. Caroline Terrill, Associate Director of Statistical Programming at Cytel UK, conducted a session “No Place Like Home: Managing Remote Programmers Remotely” and stood out as the winner in the Personnel Management category. Based on 5 years' experience of managing remote programmers, Caroline’s paper gives guidance on issues to be considered and traps to be avoided if you are managing people who work remotely.
In this blog, we share the presentations from our Statistical Programmers and summarize some of the sessions that our team members attended.
October 3, 2019 was an important day for the ADaM team as it marked the release of the ADaM Implementation Guidance (Ig) 1.2. Download the new guidance from the CDISC website here.
In 2018, several previews of the new Ig were made at CDISC Interchanges all around the world and at PhUSE conferences, it was only a few weeks ago that the final version was released. At first glance, the new Ig does not seem to contain a lot of new concepts and ideas. However, a critical and in-depth review clearly shows the efforts of the entire team to release this new Ig. Creating a new standard or releasing a new version of an existing standard is not an easy job. You need to ensure that you do not introduce anything that contradicts any of the existing CDISC standards. This includes, not only new variables but also any changes in existing sentences or adding entirely new sections that may cause misinterpretations or discrepancies. Moreover, every standard team member comes with their own background, company needs, and specific indication needs. It is not always easy to propose a solution that can satisfy everyone on the team.
In this blog, from our career perspectives series, we talk with Jayshree Garade Associate Director, Statistical Programming about her truly global career path at Cytel. Jayshree completed her Masters degree in 2006 and began her professional career with Cytel in Pune India. In the years to follow she supported high profile trials for a number of sponsors, before transferring to our offices in Massachusetts USA. She is currently leading a programming team, working remotely from her North Carolina home. Read on to learn more about life and opportunities at Cytel.
Career Perspectives: Interview with Tina Checchio, Associate Director, Quantitative Pharmacology & Pharmacometrics
QPP remains at the heart of model based drug development. Short for Quantitative Pharmacology & Pharmacometrics, it refers to several types of quantitative modeling including meta-analysis, PK/PD, statistical modeling and the modeling of go-no-go decision rules. Cytel’s expert Quantitative Pharmacology and Pharmacometrics group delivers high quality solutions to help our customers get those decisions right.
In this blog we talk to Tina who lives in Stonington, Connecticut, to find out more about her career path, current role at Cytel, and her interests outside of work.