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eClinical Solutions logo
eClinical Solutions

We bring people and data together to support tomorrow’s breakthroughs

Senior Statistical Programmer

Software EngineerSoftware EngineerOtherRemoteSeniorTeam 201-500Since 2012H1B SponsorCompany SiteLinkedIn

Location

Massachusetts

Posted

105 days ago

Salary

$115K - $130K / year

Seniority

Senior

Bachelor Degree5 yrs expEnglishGCPSDLCSQL

Job Description

Senior Statistical Programmer

eClinical Solutions

• Perform the role of Lead Statistical Programmer for assigned projects • Continually seek ways and means to provide more efficient and effective programming practices • Develop specifications for SDTM datasets and SDTM datasets specifications for Clinical Data Analysis (CDA configuration) module in elluminate • Develop SAS programming to produce SDTM datasets and SDTM datasets for CDA configuration • Develop specifications for Analysis Data Model (ADaM) datasets • Develop SAS programming for ADaM datasets • Responsible for developing and maintaining programming and validation specifications for TLGs as per requirements provided by the Biostatistician • Create and maintain SAS programs to produce outputs to support the analysis and reporting of clinical trials • Develop analysis datasets for trial level reporting and integrated safety and efficacy activities • Program and QC data listings, summaries and Graphs as defined in SAP. If required, validate the statistical models used for programming • Develop re-usable utility macros in order to build a macro library to support programming tables, listing and graphs for phase 1-4 clinical trial reporting • Collaborate with the project team to ensure the deliverables are completed on time with high quality • Create submission-ready standard data presentations and data sets using standard coding and following standard industry processes including SDLC • Maintain all project documentation as required by SOP and Processes • Mentor statistical programmers • Ensure compliance with eClinical Solutions and industry quality standards, guidelines and procedures

Job Requirements

  • Bachelor’s degree or equivalent work experience preferred
  • 5+ years in Pharmaceutical/Biotechnology industry or equivalent IT consulting role preferred
  • Strong experience in preparations for NDA filings
  • Strong knowledge of ICH/GCP guidelines, 21 CFR Part 11 and clinical trial methodologies
  • Knowledge of coding dictionaries (WHO, COSTART, ICD-9, MedDRA)
  • Knowledge of CDISC® related data models like SDTM, and ADAM
  • Experience of working on multiple clinical protocols at the same time
  • Excellent verbal and written communication skills
  • Detail oriented, ability to multitask with strong prioritization, planning and organization skills
  • Excellent team player
  • Experience of extracting, manipulating, merging, summarizing, analyzing and presenting data using SAS procedures
  • Strong experience of base SAS programming, Proc SQL, macro programming, ODS and various SAS modules: SAS/GRAPH, SAS/STAT and other modules like SAS/Connect and SAS/Access is a must
  • Experience with reporting environments and reporting tools related to SAS programming in pharmaceutical industry; proc report, proc summary and proc tabulate
  • Strong experience in SAS programming in various phases of clinical trials
  • Experience in pooled data analysis and programming
  • Strong experience in efficacy reporting with regards to development of analysis sets and treating missing values
  • Experience in working with relational databases and performance tuning of SAS programming
  • Experience with writing batch scripts and/or shell scripts is a plus

Benefits

  • Health insurance
  • 401(k) matching
  • Flexible work hours
  • Paid time off
  • Remote work options

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