Job Title: Statistics Specialist – Clinical SupportDepartment: Clinical Affairs / Data AnalyticsLocation: SS Innovations Pvt. Ltd., Gurugram, IndiaExperience Required: 3–5 YearsReporting To: Team Leader – Clinical Support Data Analysis / Clinical Affairs ManagerJob 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.
Job Title
Statistics Specialist – Clinical Support