Primary Responsibilities:
This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.
Portfolio Delivery
- Program and test data reporting, dashboarding and analytics for a trial or set of trials within a program using data standards library.
- Ensure data reporting and analytics are delivered accurately, efficiently and in alignment with study objectives
- Provide insights into study level deliverables (i.e. Data Management Plan, Project Plan, database, and observed datasets)
- Support submission, inspection, and regulatory response activities
Project Management
- Increase speed, accuracy, and consistency in the development of reporting and analytic capabilities and deliverables
- Partner with Clinical Data Management Associate to deliver data reporting and analytics per business need
- Comply with data standard decisions and strategies for a study and/or program
- Utilize therapeutic knowledge and possess a deep understanding of the technology to develop data reports and analytics
- Effectively apply knowledge of applicable internal, external, and regulatory requirements/expectations (MQA, CSQ, MHRA, FDA, ICH, GCP, PhRMA, Privacy knowledge, etc.) to all deliverables
Enterprise Leadership
- Continually seek and implement means of improving processes to reduce data reporting/analytics and decrease work effort
- Represent Data and Analytics processes in cross-functional initiatives
- Actively participate in shared learning across Data and Analytics organization
- Work to Increase re-usability of reports and analytics
- Work to enable automation and seamless data delivery with real time data validation
Minimum Qualification Requirements:
- Minimum Bachelor’s degree in Computer Science, Engineering, Statistics, Technical Science, or related field with 3-5 years of clinical experience in a pharmaceutical, biotech, CRO, or Regulatory agency.
- Technical knowledge to develop requirements and/or study project deliverables
- Knowledge and experience with statistical techniques
- Programming languages - Industry tools and languages like Tableau, PowerBI, Python, SAS, ‘R’ and Shiny for reporting, metrics, and visualizations along with P-SQL, T-SQL for DBMS.
- Proven ability to work creatively and analytically in a problem-solving environment.
- Quick learner to new trends in technology.
- Excellent leadership, communication (written and oral) and interpersonal skills.
- Demonstrated leadership in professional setting.
- Demonstrated teamwork and collaboration in a professional setting.
- Job located in Bangalore, India
Preferred skills:
- Clinical background with solid experience in data reporting and visualization using SAS and R.
- Proficient in Power BI, with strong skills in DAX coding and the ability to debug M code (preferred).
- Foundational understanding of statistical concepts.
- Basic exposure to the Python & Django framework.