- 15 Corporate Pl S, Piscataway, NJ 08854, USA
KVRA Tech Inc. has rapidly expanded into a leading provider of Technology Solutions. With development center in Piscataway, New Jersey and key global partnerships, KVRA Tech has proven itself capable of tackling projects, regardless of scale and complexity.
KVRA Tech’s abilities range from Design of Clinical Trials to Biostatistics and from Big Data to Business Intelligence and Business Analytics. We also have a large consulting, technical recruiting and training team, with expertise in a variety of platforms, both major and niche. Complexity is what drives us. We have a great pool of Statisticians, SAS Programmers, R Programmers, Data Scientists, Data Analysts, Python Programmers, Health Care Analysts, and Big Data Architects. Our wide-array of talent, coupled with our deep understanding of technology, makes us the perfect potential partner for mid-size to fortune 500 companies.
We offer a range of engagement models such as strategic consulting, value-added staffing, turn-key projects offshore leveraged extended-delivery models and a number of outcome-oriented collaborative development models.
KVRA Tech Inc has openings for Statistical Programmers in Piscataway, NJ and other unanticipated locations nationwide.
- Develop, Test, and Debug the SAS code in accordance to the interim study data lock analysis and report assessing for multiple ongoing studies using internal tools.
- Pool and Integrate ADaM datasets for the integrated summary of safety (ISS) and the integrated summary of efficacy (ISE) analysis for regulatory submissions.
- Collaborate with data management group to prepare appropriate documents in module 5 for the New Drug Applications (NDAs) in compliance with FDA regulatory for e-submission.
- Document and Refine the Analysis Data Model (ADaM) specification with regards to protocol, Statistical Analysis Plan (SAP), and Analysis Data Model Implementation Guide (ADaM IG).
- Derive and validate the ADaM datasets in accordance with specification using various SAS tools for preparing complex statistical analysis.
- Create tables, lists, and graphs (TLGs) by using SAS/REPORT, SAS/STAT, SAS/TEMPLATE, and SAS/GRAPH to provide safety and efficacy evidence.
- Conduct descriptive and modeling statistical analysis using SAS/STAT procedures, like Proc Lifetest, Proc Phreg, Proc Univariate, Proc Freq, etc.
- Perform standardized Quality Control procedures for the outsourcing tasks (source code review, independently programming, and log review) and submit qualification log report files as required by Standard Operating Procedures (SOPs).
- Work with Medical affair, Publication team etc. to understand their request for creating various Tables, Listings, Figures (TLFs) for manuscripts and abstracts for congress.
- Perform annotation of blankcrf.pdf file and review annotated blankcrf.pdf for Case Report Tabulation (CRT) package for submission to regulatory agencies.
- Develop detailed and well-written SDTM compliant specifications for the required Study Data Tabulation Model (SDTM) as per Study Data Tabulation Model Implementation Guide (SDTM IG).
- Update Study Data Tabulation Model (SDTM) specifications based on changing programming requirements.
- Map the raw datasets to SDTM datasets and generate SDTM datasets as per SDTM specification by using SAS/BASE, SAS/SQL, SAS/MACRO programming.
- Convert the SAS datasets (SAS7BADT) to .XPT file format and create the define.xml with Pinnacle 21 Enterprise software.
- Control the quality of SDTM datasets by double programming the datasets with SAS/BASE, SAS/SQL and SAS/MACRO.
- At least a Master’s degree is Statistics or a related field.
Send resume to KVRA Tech Inc: 15 Corporate Place South, Suite 369, Piscataway, NJ 08854.
At least a Master’s degree is Statistics or a related field.
All your information will be kept confidential according to EEO guidelines.