Principal Data Scientist

2 days ago

Mangalore, Karnataka, India beBeeStatistical Full time ₹ 80,00,000 - ₹ 1,20,00,000
Job Description\

As a key member of our team, the Senior Statistical Programmer plays a pivotal role in delivering high-quality statistical programming support for multiple clinical projects. With expertise in SAS and programming documentation, this individual provides expert consultation across the organization.

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This role requires strong analytical skills to process complex scientific and medical data. The successful candidate will be responsible for developing sound methodologies, ensuring regulatory compliance, and mentoring staff to enhance their programming skills.

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Key Responsibilities:

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  • Provide lead statistical programming support for multiple clinical research study projects or study teams.\
  • Develop statistical programming in SAS (Base and Macros) and provide expert consultation to projects across the company including statistical programming methodology.\
  • Ensure that sound methodologies are adopted by establishing proficiency of programming techniques required for clinical trials research which involve either CDISC standards and analysis data sets or production of standard and custom tables listings and figures.\
  • Deliver key regulatory-compliant output based on established proficiency of regulatory requirements for clinical research E-submissions and/or study requirements for Sponsor, Regulatory, Investigator or Safety review meetings.\
  • Develop programming documentation and annotations including specifications, review of mock shells, adhering to relevant Standard Operating Procedures and may contribute to standardization efforts.\
  • Write well-documented, efficient, and high-quality code, conduct code review, support cross-functional programming activities, and programming validation as needed.\
  • Stay updated on current statistical programming techniques to ensure the adoption of sound methodologies.\
  • Present statistical programming topics internally and may present at external conferences.\
  • Develop and maintain documentation and guidelines related to statistical programming procedures and best practices.\
  • Support development of new statistical methods and techniques, and participate in methodological discussions to improve statistical programming efficiency and quality.\
  • Participate in data analysis, design studies, and interpret results in collaboration with other team members.
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Requirements

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  • A bachelor's degree plus 4 years' experience in statistical programming as a CDISC/TLF programmer in a Pharmaceutical/CRO environment, education in a scientific discipline preferred.\
  • Understanding of GCP principles and other regulatory standards (e.g., FDA, EMA, and ICH guidance and recommendations) in Clinical Research.\
  • Good analytical skills with the ability to process complex scientific and medical data.\
  • Strong statistical programming skills in SAS, familiarity with R, Python, or other relevant statistical software considered beneficial.

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