The evolving role of the modern statistical programmer

Posted by Cytel

Oct 13, 2016 9:16:00 AM

Statistical programmers play a key role in turning the data from clinical trials into knowledge and supporting the development of new medicines.  In a dynamic industry with demands such as CDISC compliance, data transparency initiatives, big data, and cost pressures the role is evolving to become ever more multi-dimensional. Statistical programmers now have the opportunity to follow their specific interests and specialize in a range of areas.

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Topics: Clinical Research Services, Statistical Programming, clinical development, SAS


The CRO role in Data Standards Governance

Posted by Cytel

Aug 2, 2016 10:30:00 AM

As CDISC compliant submissions become increasingly expected, biopharmaceutical companies are considering how to approach the issue of data standards governance.  Standards governance is a lynchpin in the management of CDISC compliance and is important for promoting standards awareness within organizations. It’s also an acknowledged hot topic in the industry and formed a substantial track at 2016’s CDISC EU Interchange back in April.

It has traditionally been common practice for biopharma companies to outsource their CDISC conversion of legacy data for the purpose of publications and submissions to expert CROs.  While large biopharma organizations may have dedicated in-house teams deployed to the management of standards governance, the dynamic nature of CDISC requirements means companies can struggle to find the resources to keep up to date and provide the best interpretation of the documentation. Outsourcing can be an option to ensure dedicated staff are available to manage and monitor these aspects and ensure companies remain submission ready.

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Topics: Data Management, Clinical Research Services, Statistical Programming, Clinical Data, EDC, database build, data manager, CDM, CDISC, SDTM, ADaM, CDASH


5 trends a statistical programmer needs to follow

Posted by Cytel

Jul 25, 2016 12:00:00 PM

Statistical programmers are in high demand within the biopharmaceutical industry, and within the dynamic world of clinical trials the part they play is ever evolving.  In this blog, we take a look at 5 trends which are shaping their roles in 2016 and beyond. 

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Topics: Statistical Programming, CDISC, big data, SAS, R programming


Wild Horses: How StatXact is helping conservation project in Mongolia

Posted by Cytel

Jul 7, 2016 10:30:00 AM

 

Why do we do what we do?  At Cytel we have always been driven to deliver benefits in the service of human health, and ultimately to bring new drugs to the patients who need them.  In the context of our work in statistical software, we have recently had the opportunity to support an important conservation project defined by a similar passion to make a difference.  

While our core focus has always been in biostatistics, and thus in the life science industry, our StatXact statistical software is used by customers across a broad spectrum of natural and social sciences thanks to its ability to handle small sample sizes. 

 

The Association Takh is one such customer.  Takh is dedicated to the re-introduction of the world’s last wild horse, as well as conservation in Mongolia and improvement of the lives of Mongolian herders.  (1) In 2004 and 2005 the association reintroduced 22 Przewalski’s horses( one of the world’s most endangered species)  from Le Villaret in southern France to the buffer zone of Khar Us Nuur National Park in the Khomyn Tal herder community of western Mongolia.

 

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Topics: StatXact, Statistical Programming, exact statistics, Simulations, biostatistics, non parametric analysis


PROC MCPMod in Bronchodilator Case Study

Posted by Cytel

Jul 5, 2016 8:00:00 AM

 

At a recent PhUSE SDE, Cytel’s Chitra Tirodkar presented how East PROC MCPMod could be used  to  help solve the problem of uncertain true dose-response relationship in a bronchodilator study.  In this blog we summarize some of the issues, and make Chitra's slides available for download. 

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Topics: East, Statistical Programming, Dose-Finding, Dose Selection, MCP-Mod, EAST 6.4, SAS


The Rise of R-should SAS programmers get up to speed?

Posted by Cytel

Jun 29, 2016 8:00:00 AM

 

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Topics: Statistical Programming, Simulations, biostatistics, SAS, R programming


Sharpening your Advanced SAS Skills: Interview with Sunil Gupta

Posted by Cytel

Jun 21, 2016 10:30:00 AM


Sunil is an Associate Director of Statistical Programming at Cytel and has over twenty-five years of experience in the pharmaceutical industry.  He is also an international speaker and best-selling SAS author.  Most recently, Sunil contributes his knowledge as a CDISC Oncology ADaM reviewer and has taught his CDISC online classes with the University of California at San Diego.  Sunil has MS in Bioengineering from Clemson University and a BS in Applied Mathematics from the College of Charleston.
Recently, Sunil published a book, 'Sharpening your Advanced SAS Skills’ a follow up to his popular and well respected ‘ Sharpening your SAS Skills’. In this blog we find out more and offer blog readers the chance to win a copy of the new book!

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Topics: Statistical Programming, Training and Education, biostatistics, SAS


Managing DMC analysis- an innovative programming solution

Posted by Cytel

Jun 14, 2016 8:00:00 AM

At Cytel, we are very often asked to get involved in DMCs ( Data Monitoring Committees)  in a variety of capacities. Our statistical experts are recognized for their work in many of the areas related to DMCs including-group sequential and adaptive designs, multiplicity, missing data, and decision sciences.  One key operational management issue when producing analysis for DMCs  is that rules must be defined so that trial unblinding is not compromised and bias remains controlled.  In this blog, we will explore an innovative approach developed by members of our statistical programming team to improve the efficiency of this process, while maintaining the highest levels of data security. 

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Topics: Clinical Research Services, Statistical Programming, Interim Analyses, Blind and Unblind Trials, Clinical Data, ACES, biostatistics, DMC


Scrambled Data – A Population PK/PD Programming Solution

Posted by Cytel

May 17, 2016 8:30:00 AM

Cytel participated at PharmaSUG 2016 in Denver recently.  A key event on the statistical programming global calendar, the topics included Submission Standards, Application Development and Data Visualizaton. Sharmeen Reza, Associate Director Statistical Programming at Cytel was selected to present a paper presentation in the Statistics and Pharmacokinetics stream on the topic of Scrambled Data- A Population PK/ PD Programming Solution.  The presentation was very popular and well attended, so we've included an abstract of the presentation  below, and made her slides available for download. 

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Topics: Statistical Programming, pharmacometrics, biostatistics, pharmacology


Lost in Traceability- From SDTM to ADaM

Posted by Cytel

May 12, 2016 10:18:00 AM

 

Once upon a time Hansel and Gretel laid a trail of breadcrumbs which they followed to find their way back home.  Their story can be an allegory for the concept of traceability in clinical data where we need to  lay a clear path to ensure that the results we have created can be reproduced. This blog looks at some aspects of a presentation Lost in Traceability  by Angelo Tinazzi at the CDISC EU Interchange. 

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Topics: Clinical Research Services, Statistical Programming, FDA, Clinical Data, CDISC, SDTM, ADaM, EMA, PMDA, Biometrics


5 Hot Topics from the CDISC EU Interchange

Posted by Angelo Tinazzi

May 4, 2016 7:00:00 AM

Last week was the CDISC EU Interchange conference in Vienna, a key event on the calendar for Cytel’s statistical programming subject matter experts . Angelo Tinazzi, Director, Statistical Programming, Clinical Data Standards and Clinical Data Submission at Cytel co-chaired the sessions on Foundational Standards and Standards Governance alongside Astrazeneca’s Daniel Graham, and delivered a presentation on Traceability within the Foundational standards track.

In this blog, Angelo highlights some of the hot topics which emerged from the presentations he attended during the meeting. 

 

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Topics: Clinical Research Services, Statistical Programming, FDA, Clinical Data, CDISC, SDTM, ADaM, EMA, PMDA, Biometrics


Mind the Gap! How to prepare for SDTM migrations.

Posted by Cytel

Mar 8, 2016 9:30:00 AM

Data standardization is critical to ensure successful regulatory submissions. While many sponsors now choose to create CDISC compliant outputs as part of their in-line study analysis and reporting, inevitably legacy conversion of older studies is required.

A legacy conversion project is one which requires a significant transformation effort, where neither CDASH nor SDTM has been used. Migrating to SDTM is of course a complex activity, requiring a precise and intelligent approach- it’s not just a matter of renaming variables.  A gap analysis which assesses the current state of the data can ensure the project is commenced on the right footing.  In the below example, we conducted a gap analysis as part of a project for a client who engaged Cytel for support with their ISS/ISE.

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Topics: Statistical Programming, ISS, ISE, CDISC, SDTM


Being a Statistician: An Art, a Science or Just Job?

Posted by Cytel

Oct 8, 2015 4:25:00 PM

A recent American Statistical Association conference featured a town hall meeting to discuss the role of the statistician within the pharmaceutical industry, and in particular within the subfield of precision medicine. The panel of distinguished academics, regulators and members of industry confronted the concern that the era of precision medicine heralds an emerging need for statisticians to play a different role than the ones normally associated with technique and craft. Statisticians are now charged with discovering insightful applications to new statistical methodologies, and ensuring that clinical development reflects as many innovative statistical methods as necessary to achieve a successful study. According to the panel, statisticians may even find themselves in a position where they are required to anticipate scientific and technological advances for a study’s benefit.

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Topics: Statistical Programming, statistical communication


Clinical Impact Beyond 'Time to First' Analyses

Posted by Esha Senchaudhuri

Oct 21, 2014 9:00:00 AM

Every year, the East Users Group Meeting brings together notable experts from industry and academia to discuss the future of biostatistical advances in clinical trials, as well as the role of software in facilitating these breakthroughs. In honor of this year’s event, which will be taking place at the Loews Hotel in Philadelphia on October 22, the Cytel Blog will spend the next couple of weeks providing glimpses into the range of discussion presented at the EUGM table.

One debate that has already received quite some attention, involves the weighting of various morbidities in studies with composite endpoints. In a 2013 editorial in the European Heart Journal of the European Society of Cardiology, EUGM speaker Professor L.J. Wei and his colleagues wrote, "A reported P-value must not be confused with an assessment of the magnitude of a treatment's effect in a way that is meaningful to the patient, the clinician and the regulator." [1]

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Topics: East, East 6.3, Statistical Programming, Statistical Puzzles, Statistical Analysis, Cardiovascular


Statisticians on Software Development Part II: The Philosophy Behind a Software Package

Posted by Esha Senchaudhuri

Sep 25, 2014 10:06:00 AM

 

East: Learn More  StatXact: Learn More Compass: Learn More

A few weeks ago, we posted a synopsis of an event held at ISCB Vienna in which statisticians from Cytel, SAS and Stata spoke about processes for developing software for statisticians. The button below will guide you to a copy of the presentation by Cytel's Vice President of Consulting, Yannis Jemiai.

In the presentation, Yannis talks about the decision-making process behind software development, and how it aligns with a general philosophy to empower, simplify and educate. He explains how software developers choose from a variety of statistical algorithms in putting together a classic software package. "Just because we can," he cautions, "doesn't mean that we should." 

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Topics: East 6.3, Cytel Consulting, Regulation, Statistical Programming, Entrepreneurship


Cytel's CliPLab: Training the Next Generation of Clinical Programmers

Posted by Esha Senchaudhuri

May 27, 2014 7:09:00 AM

Although collaboration between industry and academia has been a longstanding tradition in the field of drug development, existing industry forces are reshaping the nature of this partnership. According to Cytel India's Chief Executive Ajay Sathe, the projected expansion of the drug development market between now and 2017, comes at a time when both industry and academia are challenged to supply new and innovative young talent. While some universities offer comprehensive programs in computation, programming, biostatistics and bioinformatics, such an all-encompassing curriculum is rare. Even when possible, the combined contributions of these disciplines to the day-to-day challenges of statistical analysis and data management are often difficult to comprehend without industry experience.

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Topics: Clinical Research Services, Cytel CliPLab, Statistical Programming, Training and Education


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