Associate Director, Statistical Services, PCS
IQVIA provides scientific services spanning clinical trials, real world evidence, and consulting in all areas of the product lifecycle. The Patient Centered Solutions (PCS) team leads the industry in breadth and depth of Clinical Outcomes Assessment (COA) and Patient Reported Outcomes (PRO) knowledge. Our diverse team of experts works together to develop, execute, and validate psychometric instruments that capture the patient experience with their treatment or disease, analyze and interpret outcomes, and translate the information to advance the initiatives of life science companies.
Role & Responsibilities
As an Associate Director, you will provide scientific advice and leadership and coordinate the development and completion of analysis plans to ensure the patient’s story is appropriately captured and caveated in research activities. You will conduct and translate qualitative and quantitative data into meaningful value messages and communicate these to pharmaceutical and biotech companies, regulatory authorities, payer organizations, healthcare professionals, and patient advocacy groups.
Specific role activities include:
- Development and validation of instruments aimed at measuring COAs in the context of clinical trials and/or observational studies
- Development of COA endpoint strategies for pharmaceutical and biotech companies
- Serve as a statistical consultant on client projects by providing a combination of hands-on analysis of COA data (psychometric validation of COA measures and efficacy analysis aimed to demonstrate differential treatment effect), as well as project scoping and analysis plan development
- Providing interpretation of COA data, including preparing reports, dossiers, abstracts and manuscripts presenting COA results, and explaining statistical methodology and results to different audiences
- Participate in business development activities, including proposal writing and bid defense, etc.
- Contribute to the development and maintenance of departmental policies, procedures, training and standards
- Provide oversight tracking and monitoring for client engagements, delivering high levels of quality/added value
- Participating in external thought leadership
Strong candidates will exhibit a creative approach to analysis and modeling and an interest in client interaction. Additionally:
- Advanced knowledge of complex statistical methods that apply to Phase I-IV clinical trials (multivariate analysis, regression analysis, logistic analysis, survival analysis, mixed models repeated measures, etc.) or psychometric validation methods, including classical and optionally modern test theory
- Ability to effectively communicate statistical concepts and communicate scientific evidence, with strong written and verbal presentation skills
- Possess excellent interpersonal and communication skills and be a team player
- Record of high-quality, peer reviewed COA, outcomes research and/or epidemiology research publications is a plus
- Experience with PRO/COA requirements for regulatory and HTA/reimbursement agencies including a strong understanding of the FDA Patient Reported Outcomes Guidance is a plus
Minimum Required Education and Experience
- A minimum of 5+ of relevant experience (pharma/life sciences industry) with a Bachelor’s degree in a related discipline (Biostatistics, Statistics, Psychometrics, HEOR, Health Services Research, Epidemiology); Master's or PhD is highly preferred.
- Experience with programming SAS or R, SPSS, MPlus or familiarity with implementation of statistical design and analytic methodology in other software
IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com
We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/eoe
As the COVID-19 virus continues to evolve, IQVIA’s ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding vaccination status. https://jobs.iqvia.com/covid-19-vaccine-status
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