Senior Biostatistician - Center for Statistics in Drug Development at IQVIA

Our biostatisticians support endpoint selection, sample size estimation and re-estimation, simulations, advise on state-of-the art design approaches and analysis methods, and assist with data displays and interpretations of data analysis results, based on machine learning or other complex data analyses. Our experienced biostatisticians serve as statistical consultants, both internally and externally, provide statistical thought leadership, and advise on advanced statistical methods. Their early engagement aims to identify gaps in the drug development strategy and in proposed study designs — at the time of synopsis writing.

The CSDD group’s expertise in design types include biosimilars, adaptive designs, seamless designs, dose-response designs, master protocols, Bayesian methods and analyses. This group engages in publishing papers in peer-reviewed journals, refereeing and editorial work, and presenting talks at scientific conferences and at internal and external webinars.

Job Overview:

1. Develop statistical methods sections of protocols and review case report forms (CRFs).
2. Prepare analysis plans and write specifications for analysis files, tables, and figures.
3. Communicate with clients regarding study protocol or statistical analysis issues as they arise and communicate with study team members regarding study execution as it relates to timelines, data quality, and interpretation of results.
4. Interpret analyses and write statistical sections of study reports.
5. Accountable for controlling costs and maximizing revenue recognition.
6. Performing protocol development, sample size calculation and CRF’s review’s
7. Acting as a statistical team lead for single, complex studies or groups of studies
8. Coordinating the development of statistical analysis plans, table shells, and programming specifications
9. Managing scope of work and budget, providing revenue and resource forecasts
10. Consulting on operational, statistical, and therapeutic area topics
11. Preparing proposal text and attend bid defense meetings if needed
12. Acting as a primary point of contact for the study team - communicate with team members regarding execution as it relates to timelines, budget, data quality, and interpretation of results
13. Providing expert statistical input and review of deliverables for validation requirements
14. Reviewing of the clinical study report to ensure statistical integrity in the reporting of the results
15. Interpreting analysis and crafting statistical sections of integrated reports
16. Providing training and mentoring to team members and department staff

Requirements:

1. PhD or MSc degree in Statistics, Biostatistics, or related field, along with 5 + years’ experience within the life-science industry, PhD preferred.
2. Strong knowledge of complex or advanced statistical methods and good expertise in implementing and applying them in clinical trials
3. Must have experience with clinical trial design, adaptive design strongly preferred
4. Must have solid work experience in regulatory health authorities’ environment (FDA, EMEA,…) and with compliance within the pharmaceutical and CRO space.
5. Strong working knowledge of SAS or R and CDISC SDTM and ADaM
6. Ability to effectively manage multiple tasks and projects, ability to excel at communicating and explaining statistical concepts