About
Summary
Ten years of experience as a Biostatistician in the field of Clinical Research (India and Saudi Arabia).
Awarded two Gold medals for the excellence in B.Sc. and M.Sc. Statistics examinations.
Experience in Designing of different clinical research studies and clinical trials, statistical analysis plan, sample size calculation, preparation of randomization schedule, clinical data management, case record form designing, data discrepancy management, medical coding of data, data validation, statistical analysis report writing and presentation.
Experience in managing projects involving quality improvement and patient safety; Implemented quality improvement tools and provided the necessary training on their use; Helped to develop risk-management and quality improvement strategies for the hospital wide compliance to the goal and objective of the joint commission (JCI)
Proficiency in SAS, SPSS, R, EPI Info and MS office softwares.
Knowledge of Pharmacokinetic parameters & calculations, Bioequivalence analysis, phase-I & IV drug trials statistical analysis with case studies, table listing figures (TLF), different regulatory requirements and CDISC Standards- SDTM & Adam
An independent statistical consultant with more than 10 years' experience of providing statistical advice, statistical analyses and interpretation of statistical results to clients. Clients from different disciplines like medical, engineering, nutrition science and social science etc.
Positions
Biostatistician Feb 2018 -
Manjushree Research Institute of Ayurvedic Science
Contributes to expanding research and teaching missions of the Department, through research and training.
Prepares complex and detailed documentation for research and conference papers
Literature reviews and/or analysis of project data
Autonomous coordination of research projects including the design, maintenance and use of complex electronic an paper based information systems, project data bases, internal and external websites
Designs biological data collection process resulting in maintenance of extensive data records, logs and provision of reporting for research projects
Independent analysis and manipulation of research data using complex statistical software such as: SPSS, SAS and Epi info
Conducts research including preparation, sampling, data collection and analysis and preparation of results and reports
Contributes to strategy development and reviewing operating models and developing and implementing improvements
Teaches Biostatistics and Research Methodology to graduates students
Performs other related duties as assigned
Biostatistician Aug 2017 - Oct 2018
Provides biostatistical consultation to clients
Reviews methodological aspects of research proposals, provides advice as to appropriate statistical methods
Calculates Sample size requirements for research projects
Analyze clinical or survey data using statistical approach
Designs trial methods, randomization and statistical methodology
Identifies and resolves problems related to clinical data
Develops or implements data analysis algorithms
Provides complete and timely answers to routine questions from clients
Validates and processes data using statistical software
Responsible for data processing for accurate relocation, formatting, generating and transmitting required data
Conducts statistical analysis plan of clinical data and interprets results
Generates accurate and detailed statistical analysis reports for research studies
Prepares articles for publication
Updates knowledge in statistical concepts, methods, and techniques
Maintains state of the art statistical applications in clinical research
Biostatistician May 2016 - Jul 2017
Al Kharj Military Industries Corporation Hospital
Designed clinical research studies in collaboration with physicians and other professionals
Created clinical study protocols including CRF, sample size calculation and preparation of statistical analysis plan
Managed periodic assessment of ongoing research studies
Maintained clinical research database and analyzed it using statistical approaches
Prepared clinical research reports and presentations
As a member of the research ethics committee; Provided input into clinical study protocol and reviewed/approved statistical analysis plan
Shared with the investigator in the important decision making or planning within the research in department
Independently developed new research projects
Provided biostatistical consultation to the other colleagues
Assisted in the preparation of articles for publication or presentations
Managed projects involving quality improvement and patient safety
Implemented quality improvement tools and provided the necessary training on their use
Helped to develop the quality improvement strategies for the hospital wide compliance to the goal and objective of the joint commission
Developed check list for documentation review
Achieved successfully implementing evaluation and monitoring of strategic objectives
Prepared monthly, quarterly and annual statistical reports and submit such reports in a timely manner
Participated in the education of the hospital staff during the workshops
Performed other job related duties as required
Non-Medical Research Officer (Scientist B) Aug 2009 - Nov 2015
Field Unit of National institute for Research in Reproductive Health
Designed and maintained the database of clinical research projects’ data
Monitored clinical trials throughout its duration to make sure adherence to established procedures
Interfaced with Clinical and other departments to assure smooth coordination activities
Verified the consistency of the data entered on to the CRF with patient clinical notes
Calculated sample size for research projects as required
Developed and maintained statistical programs as necessary to perform analyses, to prepare data displays and to verify data accuracy
Prepared statistical analysis of clinical research projects and wrote findings for research reports
Interacted with and served on project team, Coordinated and led development activities for projects, Accepted unique and new assignments, completed work on times
Attended conferences and meetings, participated in discussions, used an analytical approach,Focused on deliverable and provided constructive criticism
Provided Strong experience of developing a coalition of support for strategic planning and converting consensus into action
Balanced multiple task assignments and communicated to seniors to obtain needed resources
Assisted or responded to queries working in collaboration with headquarter
Coordinated with consultants and students and resolved statistical issues for their project or thesis
Processed and maintained a broad overall knowledge in the field of Biostatistics and clinical trials design /analysis by reading related literature, self-training, attending training classes
Assisted in the development of new initiatives for technical enhancements and process improvements
Data Analyst Apr 2009 - Jul 2009
Sanskar Management Professionals
Manipulated, cleansed & processed data to the desired format
Loaded, extracted and validated the data
Analyzed raw data, drawled conclusions & gave recommendations
Checked of supplied data for sense, consistency and accuracy
Data entered, data validated & created data reports
Designed and implemented new functionality
Advised on the suitability of methodologies and suggesting improvements
Supplied qualitative and quantitative data to colleagues & clients
Maintained Data-Backup, updated data for providing global trade management and compliance
Education
Pharma-Stats 2018 - 2018
Field of study: Advance Post Graduate in Pharmaceutical Statistics
Degree: Certification
Pharma-Stats 2018 - 2018
Field of study: Statistical SAS Programming & CDICS-SDTM & ADaM Theory
Degree: Certification
SAS Institute Inc 2011 - 2011
Field of study: Base SAS Programmer for SAS 9.0
Degree: Certification
Sardar Patel University 2010 - 2010
Field of study: Certificate Course on SPSS
Degree: Certification
The Maharaja Sayajirao University of Baroda 2006 - 2008
Field of study: Statistics
Degree: Master of Science
The Maharaja Sayajirao University of Baroda 2003 - 2006
Field of study: Statistics Mathematics Physics
Degree: Bachelor of Science
Skills
• Experience in designing of different Clinical Research Studies and Projects, Statistical Analysis Plan, Sample Size Calculation, Preparation of Randomization Schedule, Clinical Data management, Case Record Form Designing, Data Discrepancy Management, Medical Coding of Data, Data Validation, Statistical Analysis Report Writing, Presentation of Clinical trials and Publication in reputed journals
• Experience in Managing Projects involving Quality Improvement and Patient Safety; Implemented Quality Improvement tools and provided the necessary training on their use; Helped to develop Risk-Management and Quality Improvement strategies for the hospital wide compliance to the goal and objective of the joint commission (JCI)
• Proficiency in SAS, SPSS, R, EPI Info and MS office software
Professional interests
Clinical Research
Healthcare
Pharmaceutical Industry
CV
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