Dataplus Pharma Services, Inc.

DATAPLUS іѕ аlwауѕ lооkіng fоr ѕресіаl іndіvіduаlѕ thаt understand where wе are at tоdау аnd wаnt tо bе an integral раrt of оur grоwth and thе incredible ѕuрроrt we рrоvіdе thе community аnd оur сlіеntѕ. Wе are аlwауѕ lооkіng for реорlе with thе hіghеѕt lеvеl оf сhаrасtеr, great hоре fоr the future аnd superb communication ѕkіllѕ.

Thаnk you fоr your іntеrеѕt in wоrkіng with DATAPLUS.

Currently, we are looking for individuals to handle the following areas of our organization:


Statistical Analyst


Responsibilities:

Conduct statistical analysis of the clinical trial data by various analytical methods using different statistical packages including SAS - Statistical Analysis System software, SQL, R, SPSS, Python, S-PLUS or MATLAB, XML and Oracle Clinical and apply business logic; apply statistical theory and methods to collect, organize, interpret, and summarize numerical data to provide usable information; develop software applications or programming to use for statistical analysis, implementing data standards and generating Define-XML; review of SDTM mapping specifications; validate SDTM datasets, Tables, Listings and Graphs (TLGs); develop and maintain Datasets as per the CDISC’s (Clinical Data Interchange Standards Consortium) SDTM and ADaM standards; plan data collection methods for specific projects and determine the types and sizes of sample groups to be used; evaluate the statistical methods and procedures used to obtain data to ensure validity, applicability, efficiency, and accuracy; support regulatory electronic submissions to Food and Drug Administration (FDA) and other worldwide regulatory authorities; generate deliverables by implementing the Statistical Analysis Plan (SAP) and applying appropriate Mathematical Models as per the study design; develop or implement data analysis algorithms; update and maintain computer programs or software packages to handle specific jobs as per the requirements; handle day to day Ad-hoc requests and work on SAS ISS and ISE Tables; prepare detailed workflow charts and diagrams that describe input, output and logical operation and convert them into a series of instructions coded in a computer language; use SAS applications to generate reports; generate flowcharts and graphs to work progress; will also be using SAS/Base, SAS/Macros, SAS/QC, SAS/STAT, CRF’s, SAS Transport Files, Oracle Clinical, Oracle, PL/SQL, XML and SDLC.

Requirements:

Masters in Computer Science, Engineering, Math, Life Sciences or related field of study.


Medical Affairs/Regulatory/ Medical Writing Professionals


Responsibilities:

  • Work with clinical, regulatory, and administrative staff.

  • Prepare U.S. regulatory filings.

  • Maintain current knowledge of FDA and international regulation, guidance and standards applicable to company products.

  • Maintain the External Standards database.

  • Submission of Registration documents, progress reports, supplements and amendments.

  • Address questions and issues that arise as part of the registration and/or testing process.

  • Organize regulatory information resources and track submissions.

  • Provide status information to regulatory management as required.

  • Ensure the timely and accurate filing of regulatory documentation.

  • Maintain current regulatory knowledge of domestic and international regulations, guidelines, and standards and apply appropriate implementation strategies.

  • Represent regulatory and quality function on project teams and provide input on regulatory strategy.

  • Review and approve advertising and promotion materials in compliance with FDA regulations and guidelines.

  • Support internal and external audits as needed.

  • Perform other regulatory affairs duties when requested.

Requirements:

  • Masters Degree in Regulatory Affairs.





DATAPLUS is an equal employment opportunity employer and does not discriminate against any applicant because of race, color, religion, sex, sexual orientation, gender expression and identity, national origin, ancestry, age, mental and physical disability, genetic information, any veteran status, military status or application for military service, or membership in any other category protected under applicable law.


DATAPLUS is an e-Verify employer