Our Mission
To empower biopharmaceutical companies with the greatest probability of success through unmatched expertise and quality in biostatistics.
NJS Associates Overview
Founded in 2011 by expert biostatisticians, NJS is a specialized CRO that provides biostatistics and statistical programming services to biotech and pharmaceutical companies that are underpinned by industry leading expertise in bio statistical methodologies.
We offer a comprehensive range of biometrics services that are available in both unit and FTE based client-engagement models. Our current partners include a wide-ranging list of companies from virtual biotech firms to large pharmaceutical manufacturers. We have successfully supported more than 100 clinical trials and the FDA approval of ten medicinal products to date.
At NJS we understand that biostatistics in clinical trials isn’t just a necessity, it can be a real competitive advantage. NJS empowers small biotechnology companies with the same level of bio statistical expertise that is typically only found at large pharmaceutical companies that have teams of research statisticians. Our expert statisticians utilize state of the art adaptive, Bayesian methodologies to optimize speed, and efficiencies. But most importantly, we deliver valuable insights that increase the probability of your drug candidate’s success. At NJS we are committed to delivering the highest standards in bio statistical methodologies, which we consider to be a hallmark of the company.
With the same level of expertise applied in SAS programming as in biostatistics, combined with our own in-house oncology specific proprietary SAS macro system, NJS is particularly strong in validated oncology investigator assessments. NJS provides bio pharmaceutical companies the ability to fully validate (RECIST, iRECIST, Cheson Criteria, IWCLL, PCWG, IMWG) the quality of efficacy data efficiently. Our SAS macro system is second to none in the industry and has been used for the data quality review of more than 30 Phase II oncology trials.
A testament to our high-level of expertise, is that NJS has helped sponsors to achieve breakthrough designations, fast track designations, and the cancellation of an ODAC meeting for a medicinal product currently prescribed to patients worldwide.
Locations
Bridgewater Office
1170 RT-22 East
Suite 209
Bridgewater, NJ 08807
Waltham Office
Suite 209
Waltham, MA 02452
Miami Office
Suite 255
Miami, FL 33126
Industry Leader
Client Testimonials
At NJS we take ownership in the deliverables that we produce for our clients. We bring to every project a high-level of expertise, uncompromising ethical standards, and a client-focus that all culminate into outstanding results.
It is our aim to ensure that our clients always have a positive experience while working with us so that they work with us again and refer us to their colleagues. In fact, most of our business comes to us by word of mouth.
Vice President Biometrics
We began working with NJS 2014. NJS supported our pivotal clinical trials and submission package in thalassemia and MDS. Both submissions received FDA approvals.
Head of Biostatistics and Data Management
NJS supported more than twenty trials for us. The FDA didn’t have any questions in the section of the submission package that NJS generated for us.
Executive Director Biometrics
I started working with NJS statisticians in oncology event projection at my previous company. I continue to choose NJS as our biostats vendor.
Director Biometrics
NJS statisticians have supported us with adaptive study designs and the simulation of operating characteristics. The FDA granted our program with a fast-track designation status.
SAS Programming
NJS provided a rescue team that helped get our SDTM, ADaM and TLF development back on track again. They completed all of the tasks with highest quality and with a very quick turnaround time.
Clinical Operation
NJS supported iRECIST derivations based on raw data. It was critical to the success of our trial.