Skills

• 10+ years of IT or Software technical experience in pharmaceutical, medical device or Biotech companies.
• Implementation, Support, or use of applications that implement statistical methods and analysis pipelines such as R and or MATLAB.
• Written and validated Matlab or R scripts in a regulated environment. (Pharma, medical device, healthcare.
• Strong knowledge of pharmaceutical/medical device regulations like GxP, FDA 21 CFR Part 11, 210, 211.
• Domain Knowledge of PK/PD applications in the research and clinical setting. Experience with NONMEM, Phoenix WinNonlin, PsN, Pirana/JS, Monolix a plus.
• Displays strong technical acumen. Suggests technical alternatives to roadblocks and bottlenecks. Able to work within teams to achieve business goals with professionalism and poise
• Proven track record of managing deadlines and scheduling workload.
• Ability to understand large complex processes in a stressful environment
• Ability to work independently as well as have ability/willingness to work in team environment.
• with development environments in the cloud, a plus.
• Ability to work independently as well as have ability/willingness to work in team environment.

Qualification

Bachelor’s degree in related area and/or equivalent experience/training