- Designs, analyzes, implements, and reports findings on targeted statistical research studies;provides assistance to researchers on experimental design and statistical research approaches, requirements, and scientific standards to advance medical knowledge and improve research in public health.
- Works with R&D team to formalize analysis plans and reporting specifications; advises as to choice of statistical analysis strategies, reliability of measurements and identifiability of models, and interpretation and presentation of statistical results.
- Builds and sustains collaborative relationships with individuals in different disciplines and serves as subject-matter expert for research teams, internal and external committees, and other constituencies and collaborators.
- Works with R&D team to leverage better statistical inferences that can be utilized for Cellworks CBM Model
- Reviews and analyzes safety reporting, biomarker analyses and other aspects of clinical trial monitoring.
- Plans and documents computer data file structure; develops, programs, manages, and maintains complex statistical databases; performs or supervises data entry.
- Uses a variety of advanced statistical software, methods, and techniques to gather, analyze,and interpret research data to derive useful information for research data; advises and assists in the development of inferences and conclusions, as appropriate.
- Develops enhancements to statistical software, as appropriate, by programming new techniques; maintains knowledge of current and emerging trends in statistical analysis methodology.
A Sample Resume will have following details:
- Experienced in ADaMS, SDTM (including Pinnacle 21), TLF’s, offline, reconciliation and vendor listings.
- Working Extensively on TLF’s programming. Have an added experience in J Review tool.
- Working of efficacy and safety analysis as part of various studies and therapeutic areas.
- Generation of DTMS(Data Transfer Mapping Specification) for SDTM domains
- Working on CRF annotations, Pinnacle 21 comments for SDTM level.
- Training SAS Module 001 for beginners and experienced level programmers globally.
- Generation of various SDTM domains, ADaM’s for multiple studies
- Generation of summary tables for safety and treated sets
- Implementing wide programming aspects like procedures and data steps for analysis
- Working on figures like line plots, forest plots, bar diagrams for efficacy analysis
- Performing CRF and SAP review to generate various study domains required for the analysis.
- SAAS certification is mandatory
- Should have studied statistics as a subject and should have sound knowledge of statistics
- Bachelor of engineering or Msc or equivalent education