ClinChoice logo
ClinChoice

The Standard of Excellence

Senior Statistical Programmer

Software EngineerSoftware EngineerFull TimeRemoteSeniorTeam 1,001-5,000Since 1998H1B SponsorCompany SiteLinkedIn

Location

Pennsylvania + 1 moreAll locations: Pennsylvania | Washington

Posted

62 days ago

Salary

0

Seniority

Senior

Bachelor Degree3 yrs expEnglishJavaPythonSQL

Job Description

Senior Statistical Programmer

ClinChoice

• Annotate Case Report Form (acrf.pdf) following FDA/CDISC or sponsor guidelines. • Develop SDTM specifications and generate SDTM datasets using SAS. • Develop ADaM,specifications and generate ADaM datasets using SAS based on Statistical Analysis Plan. • Develop Tables, Listings, Graphs, Patient Profile in support of the Clinical Study Report, Posters, Manuscripts. • Develop ADaM data, Tables, Listings, Figures for Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE). • Create electronic submission package to FDA, e.g., define.xml or define.pdf following FDA guidelines with minimum supervision. • Analyze information and develop innovative solutions to programming and data analysis challenges. • Actively communicate with statisticians for statistical input and analysis interpretation. • Follow and reinforce regulatory agency requirements during daily job. • Serve as a programming team lead and contribute to department initiative. • Provide guidance, mentoring, training for team members and help solve issues from cross-functional teams. • Review draft and final production deliverables for project to ensure quality and consistency.

Job Requirements

  • Bachelor’s/Master’s degree in Statistics, Mathematics, Computer Science, Electrical Engineering, Biotechnology or related scientific disciplines with at least 3 years of clinical programming experience.
  • Proven knowledge and training in high level computing languages such as. SAS, C/C++, Java, R, Python, MATLAB and SQL.
  • Database programming experience is a plus.
  • Proficient in decoding programming logic and assembling programming code based on logic provided and be able to explain to team members.
  • Proficient in applying concepts in Artificial Intelligence and Machine Learning in the real world.
  • In-depth knowledge of Good Clinical Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology.
  • Good understanding of clinical drug development process.
  • Strong communication skills and coordination skills.
  • Detail-oriented and ability to learn and adapt to changes.
  • Proficient in Microsoft Office Suite, e.g., Word, Excel, PowerPoint, etc.

Benefits

  • Employees can work remotely

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