Job Description

Sr. Biostats Location: Mumbai, Pune, Ahmedabad, Bangalore, Chennai, Hyderabad, Kochi, Gurgaon Mandate Skills: Thorough understanding of statistical principles and study design methodology; should have worked on clinical trials phase 1-4 Educational qualification 8+ years of relevant biostatistics and/or clinical research experience (2-3 less years required with a PhD qualification) Masters in Statistics/Biostatistics or PhD (preferred) Key Responsibilities Thorough understanding of statistical principles and study design methodology Evaluates research concepts to develop appropriate statistical methods of analysis Reviews protocols, writes statistical sections and Statistical Analysis Plans (SAPs) for assigned studies Determines methods of statistical analysis and applies statistical techniques to determine measures of central tendency, correlation, sample , significance of difference, etc. Reviews CRFs and ensures complete data collection for analysis Runs randomization techniques to generate randomization lists Prepares tables, charts, and graphs showing the results of statistical analysis Performs specialized statistical analysis involving correlation equations for multi-factorial variances and regression equations. Discusses study conduct and results with physicians and sponsors Detailed knowledge of SAS programming and procedures and other statistical software; writes edit checks in SAS; validates SAS programs Accountable and responsible for data transfer Ability to provide technical solutions to a wide range of difficult problems Works with research staff to resolve issues regarding data capture, accuracy, and completeness Assists in the development of new statistical tools and modeling protocols Documents methods, instructions, and rules for implementing new techniques and research tools Develops standard data quality review checks and validation procedures Designs predictive modeling programming for evaluating health outcomes, utilization, and costs Produces standard error analysis routines and protocols (missing data & data errors checks) Diversifies research techniques, by producing mixed qualitative-quantitative approaches to evaluating EHRs. Supports business development activities by providing input on proposals and conducting feasibilities Reviews and contributes towards completion of abstracts, posters, presentations, and manuscripts by writing the statistical sections, checking results, and reviewing content Designs predictive modeling programming for evaluating health outcomes, utilization, and costs Produces standard error analysis routines and protocols (missing data & data errors checks) Diversifies research techniques, by producing mixed qualitative-quantitative approaches to evaluating EHRs. Supports business development activities by providing input on proposals and conducting feasibilities Critical Skills Experience/ability to mentor other biostatisticians; willingness to lead and present for biostatistics related meetings. Advanced SAS programming skills for data manipulation (macros, proc SQL, data and proc steps, merging, use of first & last from proc sort, removal of duplicates, running totals, merging, use of arrays, proc template, knowledge of the output delivery system (ODS), etc.) Ability to work with multiple data sources and large datasets (millions of records) Previous interaction with FDA submission is desired; experience in design and/or analysis of surveys a plus Advanced applied statistical skills: Fisher\'s exact test, Wilcoxon rank sum tests, paired tests, linear & logistic regression, Cox proportional hazards regression Active use of surviva analysis, mixed model and/or combined qualitative-quantitative analytic techniques and related research tools Modeling with count data (Poisson and negative binomial regression) Modeling with skewed data (survival and cost data) Excellent written and oral communication skills. Ability to clearly explain and define algorithm rules. Ability to explain clearly and write statistical results in easy to understand terms. Excellent time management skills and ability to prioritize. Must be able to make necessary decisions to meet deadlines. Ability to work in a fast-paced team environment. Positive attitude in an ever-changing environment is a must. Proficient with Microsoft Word, PowerPoint and Excel and

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