RWE/HEOR Analyst/R programmer/Biostatistician,remote
TechData Service Company LLC Malvern, PA
- Expired: over a month ago. Applications are no longer accepted.
RWE Analyst, Health Economics and Outcome Research with R skills
This position will primarily support strategic product value generation initiatives at R&D through statistical programming and analytics for Observational and Real World Evidence using large health care administrative databases, electronic medical records, and registries. The incumbent will utilize SAS or R, web-based analytics tools and other programming languages to efficiently work with very large real world databases, to identify and discover target patient populations, disease prevalence and risk factors, describe drug utilization, treatment patterns and disease progression, and other exploratory questions. In this role, the RWE Analyst will work closely within a cross-functional team to execute and deliver on projects in an accurate, effective and timely manner.
• Provide statistical programming support for assigned projects, focusing on real world data analyses from large databases (e.g., Electronic Health Records, medical claims, registries etc.).
• Efficiently manipulate large databases including complex data preprocessing, filtering and manipulation.
• Assist in development of detailed protocols and SAP according to study objectives. Create table and dataset specifications, in collaboration with statisticians and study leads.
• Prepare appropriate datasets by defining patient or disease cohorts, establishing study samples, and structuring data according to research objectives and study design.
• Perform statistical analysis, generate analytic reports, tables, graphics, and slides, and communicate project findings to cross functional teams, or stakeholders.
• In addition to hands-on SAS or R programming, leverage available web-based RWE analytical tools.
• Familiar with cloud and high-performance computing environments (Azure, AWS)
• Provide technical expertise to implement programming and methodology for complex RWE studies.
• Develop and implement rigorous QC processes and programming templates to ensure quality of data and analyses.
• Assist in creation and implementation of validation activities for RWE studies following departmental SOPs.
• Ensure quality and timely deliverables for all assigned studies/projects.
• Interface with the IT department to maintain and develop cloud computing capacity and analytic tools for RWE studies.
• Collaborate effectively in a matrix and cross-functional environment with programmers, statisticians, epidemiologists, outcomes research scientists and other stakeholders across global R&D such as Medical Affairs, Health Economics and Outcomes Research (HEOR), Clinical Development, Pharmacovigilance and Regulatory Affairs.
• Ensure professional development to enhance knowledge, skills, communication, scientific methodology, operational efficiency, and compliance with policies, regulations, and corporate standards and processes.
• An advanced educational degree (MA/MS, PhD, ScD, PharmD, etc.) in a quantitative science such as statistics, biometrics, epidemiology, econometrics, psychometrics, operations research, engineering, computer science, data/life science, etc.
• Hands-on professional R or SAS programming experience i
• A minimum of 2 years hands-on work experience with real world studies using large claims/EMR databases in HEOR or related functions.
• Demonstrated experience and knowledge working with Truven/IBM Marketscan data and similar healthcare databases.
• Knowledge and experience in developing analysis and reporting deliverables for R&D projects (data, analyses, tables, graphics, listings).
Perform Clinical Data Analysis: Summarize and tabulate clinical data using R language
Statistical Modelling using R for easy use
• Creating figures including dynamic plots.
• Build R, SAS packages/tools as needed
· At project level, ensures the study designs are scientifically sound, the efficacy and safety endpoints meets regulatory requirements.
- Provide statistical support to Clinical Development Plan for multiple compounds
- Participate in pre-IND and NDA/BLA activities
- At study level, provide statistical input to study protocols, develop statistical analysis plan
- Assist in writing relevant sections of the clinical study report and publication
- Monitor internal and CRO project activities including timelines, deliverables and resources
- Ability to use SAS to perform efficacy analyses and validate important data derivations when necessary.
- Develop and implement department standards and lead process improvements
- PhD or MS in Biostatistics or Statistics;
- Three to ten years of experience as statistician in Pharmaceutical or Biotechnology industries;
- Good knowledge of statistical programming languages (including SAS, R);
- Solid oncology and/or hematology experience
- Experience with advanced study design or at least one NDA/BLA eCTDs or other global regulatory submissions
- Experience as an independent lead statistician with responsibility for multiple studies or projects
- Excellent interpersonal, leadership and communication skills and ability to work independently and collaboratively;
- Knowledge of SDTM/ ADAM
TechData Service Company LLC