1. Statistical Analysis: Apply advanced statistical methods to analyze clinical and diagnostic data. Provide interpretation and insights to guide the development and validation of diagnostic tests.
2. Consultation: Serve as a statistical expert to hospital teams, offering guidance on study design, data collection, and analysis strategies. Assist in formulating hypotheses and designing experiments to address diagnostic challenges.
3. Study Design and Methodology: Develop and recommend statistical methodologies for clinical trials and diagnostic evaluations. Ensure designs are aligned with regulatory requirements and best practices in the diagnostic field.
4. Data Interpretation: Analyze data from clinical trials and diagnostic studies to assess test performance, including metrics such as sensitivity, specificity, and predictive values. Communicate findings effectively to both technical and non-technical stakeholders.
5. Regulatory Compliance: Ensure that all statistical analyses meet regulatory standards for diagnostic test approvals and submissions. Prepare and review statistical sections of regulatory documents and reports.
6. Quality Assurance: Implement and monitor quality control procedures for data management and statistical analysis to ensure the accuracy and reliability of results.
7. Collaboration: Demonstrated ability to work effectively with multidisciplinary teams, including clinical researchers, engineers, and regulatory professionals.
1. Proficiency in statistical software such as R or Python.
2. Familiarity with ISO, and CLSI standards is a must.
3. Strong understanding of biostatistical methodologies, clinical trial design, and diagnostic evaluation processes. Familiarity with regulatory guidelines (e.g., FDA, EMA) for diagnostic products is a plus.
We are a national award-winning startup with a vision to develop next-generation healthcare diagnostics, incubated at IIT Guwahati. We have received various accolades, grants, and funding and have been working in collaboration with, AIIMS Delhi, GMCH, GNRC, IITK, MeitY, DBT, DST, and ICMR. You'll be able to work closely with our team and gain valuable experience in a fast-paced, innovative environment. Plus, as a part of a thriving startup, you'll get to see the impact of your work firsthand and contribute to our growth.
