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Job Title: Statistics Specialist – Clinical Support Department: Clinical Affairs / Data Analytics Location: SS Innovations Pvt. Ltd., Gurugram, India Experience Required: 3–5 Years Reporting To: Team Leader – Clinical Support Data Analysis / Clinical Affairs Manager Job Summary: The Statistics Specialist – Clinical Support is responsible for managing and analyzing clinical and operational data related to surgical robotic systems. The role requires strong statistical acumen to support clinical trials, post-market surveillance, research studies, and evidence generation initiatives. This position plays a key role in transforming complex data into meaningful insights to aid clinical decision-making and regulatory submissions. Key Responsibilities: Perform statistical analysis of clinical study data, observational studies, and retrospective reviews related to SS Innovations’ surgical robotic systems. Provide statistical input for clinical study design, sample size calculations, and protocol development. Support data management activities including cleaning, validation, and review of clinical data for accuracy and consistency. Prepare statistical analysis plans (SAP), summary tables, figures, listings, and final study reports. Collaborate with clinical, R&D, and regulatory teams to generate data-driven evidence to support safety, efficacy, and usability claims. Work with biostatistical software such as SAS, R, or SPSS to conduct exploratory and confirmatory data analysis. Contribute to scientific publications, abstracts, posters, and conference materials. Assist in preparation of data for regulatory submissions (e.g., US FDA, CE Marking, CDSCO, etc.). Monitor data trends to identify early signals, adverse events, or areas requiring further investigation. Ensure compliance with ICH-GCP, ISO 14155, and other applicable statistical and clinical research standards. Requirements: Master’s degree in Statistics, Biostatistics, Mathematics, Epidemiology, or a related field. 3–5 years of experience in a clinical or medical device/statistics role. Strong knowledge of clinical trial methodology, design, and statistical principles. Proficiency in statistical software (SAS, R, SPSS, or equivalent). Experience working with large datasets and clinical databases (EDC, CRFs, etc.). Excellent analytical, problem-solving, and documentation skills. Strong communication skills and ability to work in a cross-functional, fast-paced environment. Familiarity with global regulatory requirements and standards for medical devices is preferred. Preferred Skills: Prior experience in a MedTech or surgical robotics company. Exposure to clinical study submissions to US FDA, CE, or other regulatory bodies. Understanding of AI-assisted data models and predictive analytics in healthcare. Show more Show less
