Lead Analyst Bio Statistician, Clinical Research

About the role

Stryker is hiring a Lead Analyst Bio Statistician for its clinical research program in Bengaluru, working in a hybrid setting. The role provides statistical guidance for clinical research programs and individual studies within a multi-disciplinary team, covering statistical analysis plans, data handling, analysis and interpretation of study data.

Key responsibilities

• Provide timely, scientifically sound statistical expertise to clinical development projects and take part in department and cross-functional meetings to optimise study designs, endpoints and analysis strategies.
• Collaborate with project teams to set timelines and develop and implement protocols.
• Develop statistical analysis plans, coordinate and perform data analysis and validation, and interpret data.
• Give statistical input to regulatory requests and help publish study results with clinical scientists, thought leaders and medical writers.
• Perform inferential analyses, contribute to the statistical section of the clinical study report (CSR), and support the study team through the CSR review and approval process.
• Develop and test SAS programs to generate data sets, tables, listings and graphs, and to run quality control and validation on SAS programs, data sets and TLFs.
• Create derived variables and data sets (e.g. LOCF, adverse events) using SAS, SQL and macros, and document SAS programs.
• Guide junior programmers or statisticians.

Required profile

• MS or PhD in statistics, mathematics or a related field.
• Master's-level degree or equivalent in statistics, biostatistics or a related field with medical research content.
• Minimum of 6-9 years of relevant experience, including postgraduate years.
• Strong knowledge of regulatory guidelines (FDA/CFR; ISO 14155).
• Ability to explain statistical concepts to non-statisticians and to work independently with minimal supervision.

Required skills

• Advanced knowledge of clinical trial design and analysis.
• SAS proficiency, including nonparametric analysis, linear and non-linear models, categorical data and survival analysis.
• SQL and macro skills.
• Experience with electronic data capture (EDC) and electronic health record (EHR) systems.
• Experience supporting publication of analysis results (abstracts, posters, manuscripts) is a plus.