Lead Analyst Bio Statistician, Clinical Research

Stryker — Bengaluru, India

Work Flexibility: Hybrid Job Summary This position is responsible for providing statistical guidance in development of clinical research programs and of individual studies as part of multi-disciplinary team. This role involves the development of Statistical Analysis Plans, encompassing statistical methodology, the definition of derived variables, formulation of data-handling rules, creation of mockups, and, ultimately, the analysis of study data to meet business needs. What will you do: Essential Duties & Responsibilities: Provide timely and scientifically sound statistical expertise to clinical development projects.Participate in department and cross-functional meetings to optimize clinical study designs, endpoints, and analysis strategies. Collaborate with members of project teams to establish project timelines and to develop and implement protocolsDevelop statistical analysis plans, coordinate and perform data analysis and validation as necessary, and provide data interpretation. Provide statistical input to regulatory requests to support and defend clinical programs.Collaborate with clinical scientists, thought leaders, and medical writers, both internally and externally, in the publication of study data. Stay current with new developments in statistics, SAS programming, and regulatory guidance through literature review, conference attendance, etc.Perform inferential analyses; inputs to the statistical section of the clinical study report (CSR) and review clinical study report. Provide support for the study team to move CSR through the review and approval process. Provide statistical insight into interpretation and discussion of study results. Develop and test SAS programs to generate data sets, tables, listings, and graphs.Develop and test SAS programs to complete quality control and validation work on SAS programs, data sets and TLFs generated by others.Develop SAS programs to create derived variables and data sets (e.g., LOCF (Last Observation Carry Forward),

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