Contract SAS Programmer - NJ in Berkeley Heights, NJ at Apex Life Sciences

Date Posted: 5/29/2018

Job Snapshot

Job Description


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. 
  • Ensure consistency and adherence to standards within their therapeutic area. 
  • Provide programming support for the preparation of integrated reports, submissions and post-submission activities. 
  • Oversee the services provided by CROs. 
  • Contribute to the creation, maintenance, and validation of standards for programming tools, outputs and macros. 
  • Provide training on departmental SOPs/WPs and standard programs. 
  • Contribute to the creation of naming conventions and standards for the programming environment. 
  • Participate in industry wide technical discussions. 

KNOWLEDGE, SKILLS & ABILITIES (KSA's): 

  • Bachelor’s degree in life science, statistics, mathematics, computer science, or related field is required; Master’s degree is preferred. 
  • 8 plus years Pharmaceutical/CRO experience as a SAS Programmer supporting clinical trials for regulatory submissions with a Bachelor’s degree; or 5 plus years experience with a MS/MA degree. 
  • Experience in Oncology, Hematology Cancer (i.e. CLL) and Medical Affair Projects are preferred. 
  • Demonstrated proficiency in using SAS to produce derived analysis datasets and produce 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 interpersonal, communication, writing and organizational skills.

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