similar to: R Foundation adopts Certification/Validation document

As I work as a biostatistician in the medical devices industry, I have been very happy to take part in several conversations on this list regarding the use of R in a regulated environment. It was with great interest, therefore, that I read the new guidance document for the use of R in regulated clinical trial environments now available on the R website. The purpose of the document is

I hope that Marc doesn't mind, but I felt that part of his recent post was important enough to deserve it's own subject line rather then being lost in a 60-msg-long thread... On Sun, Jan 11, 2009 at 10:08 AM, Marc Schwartz <marc_schwartz at comcast.net> wrote: ... I strongly believe that the comments regarding R and the FDA are overly negative and pessimistic. The hurdles to

Dear Sr. of R-project: In the document "R: Regulatory Compliance and Validation Issues. A guidance Document for the Use of R in Regulated Clinical Trial Environments", in the point 6.3 say that exist a set of validation test, that are localized in the test subdirectory. I search the place in the page www.r-project.org and not found this, can you say me where is the set?. I work in a

> From: delphine.fontaine at genexion.com > To: r-help at stat.math.ethz.ch > Date: Sat, 3 Nov 2007 09:03:39 +0100 (CET) > Subject: [R] R validation > Dear R-Users, > > A message to continue the discussions we had in March and June. I have > read the documents written since then > (http://www.r-project.org/doc/R-FDA.pdf ; >

Title: Scientific Director of Statistical Modeling and Simulation Requisition #: 4146130318 URL: http://bit.ly/14valrL Scientific Director of Statistical Modeling and Simulation Janssen Research & Development, LLC, a Johnson and Johnson Company is hiring a Scientific Director of Statistical Modeling and Simulation to be located at our Spring House, PA or Raritan, NJ

The Quantitative Decision Strategies group at Janssen Research & Development, Johnson & Johnson, is looking for a candidate to represent QDS in Beijing, China in the subsidiary company of Xian-Janssen Pharmacetical Ltd. The basic requirements for this candidate are 1) 3+ years experience in a quantitative field, but not necessarily pharmaceutical; 2) PhD in statistics or related field

I have used S-PLUS, R, MATLAB and SAS for many years, and I am actually quite happy to use any of these four languages. The reason may in part involve my using the various languages for the purposes to which they seem most suited. Hence there are many things for which I would not use SAS or MATLAB, but for which I would greatly prefer to use R instead. On the other hand ( to take one of a

Dear R Developers, This is my first time subscribing to this list, so let me start out by saying thank you all very much for the incredible contribution you have made to science through your work on R. As you all know many users of commercial stat packages, their managers, directors, CIOs etc. are skeptical of R's quality/accuracy. And as the recent NY Times article demonstrated, the

Hi All, We have all had to face skeptical colleagues asking if software made by volunteers could match the quality and accuracy of commercially written software. Thanks to the prompting of a recent R-help thread, I read, "R: Regulatory Compliance and Validation Issues, A Guidance Document for the Use of R in Regulated Clinical Trial Environments (http://www.r-project.org/doc/R-FDA.pdf).

If you are interested in the following position, please contact Vladimir Svetnik at Vladimir_svetnik at merck.com. Date: Nov 18, 2015 Location: Rahway, NJ, US Associate Principal Scientist, Biostatistics-BIO004396 Description Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription

Yesterday I just noticed the new document on R and regulatory aspects for biomedical research posted at http://www.r-project.org/doc/R-FDA.pdf Coming from an institution that performs a large number of clinical trials for FDA and being an advocate of R myself, I have found that the following issues usually come up when discussing the use of R for FDA trials: 1. Most FDA submissions come down to

Dear R-Helpers, Apologies in advance as this is partly (widely ?) OT. Not sure where to ask, R is my favorite computer tool (no kidding) and there are plenty of knowledgable and helpful people on the list. Background: There are discussions among experts and regulatory authorities (cf guideline http://www.emea.europa.eu/pdfs/human/ewp/056598en.pdf) that, in for example Amyotrophic Lateral

Statistical Programmer (SAS or Splus/R) About the Company: Edwards Lifesciences (NYSE: EW) is a global leader in products and technologies to treat advanced cardiovascular disease, the global leader in acute hemodynamic monitoring and the number-one heart valve company in the world. Headquartered in Irvine, California, Edwards has more than 5,000 employees'' worldwide, selling medical

Edwards Lifesciences (NYSE: EW) is a global leader in products and technologies to treat advanced cardiovascular disease, the global leader in acute hemodynamic monitoring and the number-one heart valve company in the world. Headquartered in Irvine, California, Edwards has more than 5,000 employees worldwide, selling medical technologies in more than 100 countries. Edwards Lifesciences leverages

About the Company: Edwards Lifesciences (NYSE: EW) is a global leader in products and technologies to treat advanced cardiovascular disease, the global leader in acute hemodynamic monitoring and the number-one heart valve company in the world. Headquartered in Irvine, California, Edwards has more than 5,000 employees worldwide, selling medical technologies in more than 100 countries. Edwards

A while back i had asked about possible replacements for snom 360 phones that were breaking and causing issues and we all discussed the problems we had with the 360s and some suggestions were made but the new polycom phones had just hit the market and not many people were able to comment on them. Basically i am looking to get some new phones and in the process get rid of the countless number of

We are currently seeking a Statistical Analyst to work for a large Pharmaceutical company in the US. This position is a Work From Home opportunity. If you meet the requirements below please send your resume to Christina.Kinchen at InventivHealth.com or call 407-548-0670. REQUIRED: * The ideal candidate will have strong R programming skills and 6 months, or more, work

We are currently seeking a Lead Statistician to work for a large Pharmaceutical company in the US. This position is a Work From Home opportunity. If you meet the requirements below please send your resume to Christina.Kinchen at InventivHealth.com or call 407-548-0670. A brief description is as follows: Title of Position: Telecommuting LEAD STATISTICIAN REQUIRED: . The ideal candidate will have

Hello Everyone,   I’m a SAS user who has recently become interested in sequential clinical trials designs. I’ve discovered that the SAS based approaches for these designs are either too costly or are “experimental.” So now I’m looking for alternative software. Two programs that seem promising are SPLUS Seqtrial and R.   I recently obtained a 30 day trial for the SPLUS Seqtrial add-on and have

Dear all, The CRUK MI have multiple positions in and around bioinformatics, biostatistics and computational biology. These range from HPC and mathematical programming, through biostatistics and biomarkers, to computational biology and bioinformatics. Focuses include single cell genomics and personalised medicine in lung and prostate cancer. For full details, please visit our website at: