Biostatisticien Principal FSP – Principal Biostatistician – Pharmacocinétique
| Company | IQVIA |
|---|---|
| Location | Pointe-Claire, QC, Canada |
| Salary | $Not Provided – $Not Provided |
| Type | Full-Time |
| Degrees | Master’s, PhD |
| Experience Level | Senior, Expert or higher |
Requirements
- PhD in Statistics, Biostatistics, or related field with 5+ years industry experience.
- MS in Statistics, Biostatistics, or related field with 7+ years of industry experience.
- At least 3 years in clinical trial experience in phase 2 and 3 plus 2 years in observational/RWE studies.
- Demonstrated ability to work independently in project management and decision making.
- Able to effectively communicate his/her ideas and to manage programmers in a constructive manner.
- Proficiency in SAS to perform analyses and validate important data derivations.
- Performing sample-size/power calculations.
- Performing clinical trial simulations.
- Performing detailed literature reviews and summarization for epidemiologic data.
- Performing validation of Endpoints/Outcomes to inform study design.
- Experience with applying innovative study design and analytic techniques such as synthetic control arms, causal inference methods, rare disease methods, Bayesian techniques.
- Understanding of ICH GCP, ICH E9 plus general knowledge of industry practices and standards.
- Experience with CDISC, including SDTM, ADAM, CDASH.
Responsibilities
- Collaborate with multi-disciplinary project teams to establish project objectives and timelines.
- Write the statistical sections of clinical trial protocols, while consulting with internal and external experts.
- Write statistical analysis plans.
- Monitor internal and CRO project activities including timelines, deliverables, and availability of resources.
- Collaborate with Data Management, Clinical Development, and Clinical Operations with statistical expertise.
- Contribute to clinical study/statistical reports and other regulatory documents.
- Provide guidance and supervision to programmers in authoring of analysis dataset specifications and programming of tables, listings, and figures.
- Interpret study results and review reports of study results for accuracy.
- Support exploratory analyses and medical affairs publications.
- Participates in other activities and meetings to support Biostatistics and the Development Team as needed.
Preferred Qualifications
- Neuroscience experience
- No further specialized skills are applicable.