Job Description
TechData is looking for World Evidence (RWE) Biostatisticians for our pharmaceutical clients.
Position Summary
The RWE biostatistician provides statistical expertise for all observational research project sponsored by the US Evidence Based Medicine in protocol development, Statistical Analysis Plan (SAP) preparation and study report. The role needs to ensure that appropriateness of study design, sample size and statistical methodologies are used and adherence to the established standards and SOPs. The role manages the timely execution of statistical and research methodological components of RWE study protocols in order to meet project objectives and has a thorough understanding of current requirements for statistical standards.
Roles/Responsibilities
Utilize statistical knowledge of and expertise to provide statistical support for RWE studies, with a main focus of real-world observational studies, database examples:
1)US medical and pharmacy claims databases (e.g. MarketScan); 2) US medical record databases (e.g. GE Healthcare); 3) US government public use databases (e.g. NHANES, MEPS)
Participate in study concept, protocol and SAP development and ensure appropriateness of study design, sample size and statistical methodologies proposed.
Specify the structure of the datasets that will be delivered for statistical analysis to ensure that the structure follows any existing company standard for databases pooling.
Mock-up, review, and approve tables, listings and graphs specifications.
Actively participate in project/study team meetings
Establish/negotiate timelines for completion of study-related statistical activities. Ensure the study timelines are met.
Conduct observational data analysis, include data management, statistical programming, interpretation of analyses results, and write-up/review the corresponding sections of RWE study report.
Produce analysis datasets, listings, tables, and figures for research projects, according to specifications, while maintaining documentation and complying with pre-defined project / study standards.
Provide oversight of the biostatistics-related activities for RWE studies subcontracted to a CRO:
Oversee the CROs work on the preparation of analysis plans, development and validation of computer algorithms for inferential analyses, statistical writing of study reports, and other outsourced analyses as appropriate.
Perform quality control procedures to ensure that statistical deliverables conform to the requirements outlined in the SAP
Skills:
Ph.D. in Statistics, epidemiology or related field, or MS with Minimum 1-year experience in pharmaceutical industry; Strong programming skills.
TechData is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.
Company Description
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