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Statistical Programmer
Ref No.: 18-11832
Location: Berkeley Heights, New Jersey
Position Type:Contract
Start Date / End Date: 08/20/2018 to 02/28/2019
Sunrise System Inc. is currently looking for Statistical Programmer in Berkeley Heights, NJ with one of our top client.
Job Title: Statistical Programmer
Job Id: 18-11832
Location: Berkeley Heights, NJ 07922
Duration: 6 months
Position Type: Hourly contract Position (W2 only)
 
Core Job Functions
  • Provide programming input to CRF, SAP, analysis file specifications, and tables, figures, and listings (TFLs) shells.
  • Write SAS programs to generate derived analysis datasets, perform analysis, and TFLs.
  • Perform ad hoc flexible and rapid programming arising from questions generated from planned analyses and results.
  • Perform programming validation to ensure the quality of analysis datasets and programming outputs.
  • Ensure consistency and adherence to standards within the project.
  • Provide input to the design of the clinical trial database for proper data capture and to ensure data quality.
  • Create Data Definition Tables (DDT) and converting TFLs to the required format for submission.
  • Provide programming support for the preparation of integrated reports, submissions and post-submission activities.
  • Convert, verify and integrate multiple sources of incoming data for the creation of analysis datasets.
  • Serve as the lead programmer in support of NDAs, sNDAs.
  • Serve as an advisor to programmers assigned to the project to ensure high quality and timely deliverables.
  • Serve as a coordinator when multiple programming resources (e.g. CROs or contractors) are used.
  • Contribute to the creation, maintenance, and validation of standards for outputs and macros.
  • Provide training on SOPs, WPs and standard programs.
  • Contribute to the creation of naming conventions and development of the programming environment.
  • Oversee the services provided by CROs. 
Skills/Knowledge Required
  • Bachelor’s Degree in life science, statistics, mathematics, computer science, or related field is required; Master’s Degree is preferred.
  • REQUIRED: oncology experiences and ISS/Client
  • 7 plus years Pharmaceutical/CRO industry experience as a SAS programmer supporting clinical trials for regulatory submissions or equivalent experience.
  • Demonstrated proficiency in using SAS to produce derived analysis datasets and TFLs.
  • Thorough understanding of clinical data structures, relational database structures, and data exchange with alternate data formats.
  • Demonstrated skills in using additional software tools and applications (e.g. MS office, XML).
  • Demonstrated expertise in the handling and processing of upstream data, e.g., multiple data forms, workflow, eDC, SDTM.
  • Demonstrated expertise in providing outputs to meet downstream requirements, e.g., ADaM, Data Definition Table, e-submission.
  • In-depth understanding of regulatory, industry, and technology standards and requirements.
  • Good knowledge of statistical terminology, clinical tests, medical terminology, and protocol designs.
  • Demonstrated ability to work in a team environment with clinical team members.
  • Good planning and project management skills.
  • Good interpersonal, communication, writing and organizational skills. 
Contact
Praful Prasanna
Email: Praful.P@sunrisesys.com | Direct: (732) 272 0326
Or
Sourabh Agrawal | Lead - Talent Acquisition
Direct: (732) 272 0301| Email: sourabh@sunrisesys.com