Dur: 6 M+

Rate: OPEN

Role:Senior Statistical Programmer

Location:New York City

Noted New Jersey pharma has an immediate need for a Senior Statistical Programmer.

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.
  
• 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 eSubmission.
  
• 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.
  
• Provide training on SOPs, WPs and standard programs.
  

KNOWLEDGE/SKILLS/ABILITIES:

• 7 plus years Pharmaceutical/CRO industry experience as a SAS programmer supporting clinical trials for regulatory submissions
  
• 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) preferred.
  
• Demonstrated expertise in the handling and processing of upstream data, e.g., multiple data forms, workflow, eDC, SDTM, preferred.
  
• Demonstrated expertise in providing outputs to meet downstream requirements, e.g., ADaM, Data Definition Table, e-submission, preferred.
  
• In-depth understanding of regulatory, industry, and technology standards and requirements, preferred.
  
• Good knowledge of statistical terminology, clinical tests, medical terminology, and protocol designs, preferred.
  
• Demonstrated ability to work in a team environment with clinical team members, preferred.
  
• Good planning and project management skills, preferred.
  
• Good interpersonal, communication, writing and organizational skills, preferred.