Senior Clinical Research Scientist

Location

Bangalore | India

Job description

About the job

Job Title:

Department: R&D

Location: Bengaluru

Years of Experience: 5-7 years

Employment Type: Full Time Employment

About Qure.ai:

Qure.ai is one of the fastest-growing startups in India, which develops Artificial Intelligence enabled products and platforms for healthcare diagnostics. We create cutting-edge solutions that positively impact patients' lives in various care domains, including lung cancer, tuberculosis, and stroke. To date, our innovative technologies have reached over 12 million individuals across 75+ countries worldwide.Qure.ai is an equal-opportunity employer.

Job Description: The Senior Clinical Research Scientist will be responsible for the design, statistical analysis, reporting, and review of clinical research studies involving Qure.ai's AI software products. These studies may be completely internal studies, or they can be studies conducted in collaboration with external investigators.

Roles and Responsibilities

• Independent development of clinical research study protocol (Standalone, Multi-Reader-Multi-Case [MRMC]), Cross-sectional studies, Retrospective/Prospective Observational Studies, Case-control/Cohort, Randomized Controlled Trials) for external validation of Medical AI/ML clinical diagnostic decision support software devices.
• Independent conduct of pertinent literature review.
• Development of Statistical Analysis Plan (SAP) , including pre-hoc statistical power analysis with minor supervision.
• Work with external and internal stakeholders to guide the development and finalization of Data Dictionaries and Case Report Forms (CRFs) as and when needed.
• Conduct Quality Check (QC) of study data and statistical modeling/analysis (data cleaning/wrangling, measures of AI device accuracy such as estimation of sensitivity, specificity, Area under the curve [AUC], predictive values, statistical modeling of MRMC study data, hypotheses testing, statistical measures of association between exposure and outcome,etc.) of clinical study data with minor supervision.
• Independent drafting of manuscripts and/or abstracts for conferences and journal submissions.
• Work with External Study Collaborators/Investigators and internal stakeholders like Product Managers, AI Scientists, Regulatory Affairs professionals, and Client Success professionals during study conceptualization, study execution, and study reporting, ensuring the proper scientific quality of the study.

Skills and Expertise:

• An ideal candidate would have a medical degree (MBBS/MD) with experience and/or formal training in Epidemiology/Biostatistics or STEM subjects.
• 5-7 years of experience post-MBBS or 2-4 years of experience post-MD in the industry (preferably in Pharma/CRO/Medical Device/Healthcare Consulting industry) or academia in the design and conduct of clinical research studies.
• At least superficial knowledge of clinical decision support systems (computer-assisted diagnostic (CAD) devices) such as those based on AI.
• Previous experience in developing AI/ML models using clinical data is a big plus.
• Knowledge of guidelines such as, but not limited to, STARD, CONSORT-AI, SPIRIT-AI, DECIDE-AI, STROBE, ICMJE.
• Statistical Programming in R or Python and excellent knowledge of working with tools such as Microsoft Word or LaTeX, and Microsoft Excel.
• Knowledge of Good Clinical Practice (GCP).
• Knowledge of requirements of ethics committee approvals, informed consent forms, and clinical study registration in registries such as CTRI, clinicaltrials.gov, etc.
• Knowledge of regulatory body guidance such as those from FDA and CE. Experience in regulatory body submissions is a big plus.
• Effective communication skills.
• Experience in clinical study project management is a big plus.

A t Qure.ai

You will be part of a rapidly growing organization, with an opportunity to work alongside the best minds in the industry. Competitive compensation and rewards, opportunity to grow with a young company.

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