ProClinical is partnering with a leading management consulting firm to advertise a vacancy for a Clinical Study Assistant position. The organization, which prides itself on its leading presence as a global advisor of talent supply chain strategies and workforce solutions, is seeking for a driven and talented individual to join its US-based office. This is an exciting opportunity to work closely within a cross-functional team to execute and deliver on projects in an accurate, effective and timely manner.
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.
Job Responsibilities:
- 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 pre-processing, filtering and manipulation using SAS.
- Develop and implement efficient SAS programs and reusable macros as relevant for big data solutions and in particular RWE studies.
- 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 programming, leverage available web-based RWE analytical tools.
- 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 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.
Skills and Requirements:
- 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 SAS programming experience including data steps, procedures, SAS/MACRO, SAS/SQL, SAS/GRAPH, and Stats modules.
- 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.
- Hands-on experience working with large complex and relational databases with knowledge and efficient use of SQL knowledge.
- Knowledge and experience in developing analysis and reporting deliverables for R&D projects (data, analyses, tables, graphics, listings).
- Experience working with medical and billing coding systems such as ICD-9, ICD-10, SNOMED, LOINC, NDC, HCPCS, CPT.
- Understanding of observational research or statistical terminology and concepts is essential.
- Ability to quickly and effectively learn new programming techniques and data structures; capacity to seamlessly assimilate to new projects is required.
- Ability to comprehend analysis plans which may describe observational research and statistical programming methodology to be programmed needed.
- k on multiple tasks simultaneously in different therapeutic areas is required.
- Experience working in GxP and non-GxP environments.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Maya Smith at +267-405-6995 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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