Description

• Job Responsibilities:
  • 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.
  • Analyse 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.

Requirements

• Qualification: Master’s / bachelor’s degree in Statistics, Mathematics, Computer Science, Electrical Engineering, Biotechnology or related scientific disciplines.
• Should have experience in end-to-end statistical programming (SDTM, ADaM and TLFs).

Years of Experience

• Should have 5-8 years of experience in end-to-end Statistical Programming in Clinical domain.

Skills

• • 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. ability to communicate with global teams with supervision.
  • 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.
  • Detail-oriented and ability to learn and adapt to changes.
  • Proficient in Microsoft Office Suite, e.g., Word, Excel, PowerPoint, etc.