Bachelor or Master (preferred) Degree in Statistics, Computer Sciences, Engineering, Pharmacy, biological sciences, IT, or related field.
At least 5 - 6 years relevant experience in a pharmaceutical, biotech, CRO, or Regulatory Agency.
Understanding of clinical data and drug development process, CDISC standards required
Statistical Programming and SAS hand-on experience
Clinical trials expertise with an understanding of data operations required for the reporting of clinical
Good understanding of ICH and regulatory guidelines
Working knowledge of clinical data and relevant data standards
Is able to work with stakeholders across timezones under tight timelines
Strong written and oral communication skills, and time and project management skills
Strong competencies and interests for innovation and problem solving
Proven ability to operate with limited oversight
Knowledge of at least 1 Therapeutic Area
Principal Data Scientist • Chennai, India