Penfield Search Partners
Contact: Neisha Camacho/Terra Parsons firstname.lastname@example.org
Job Description: Principal Statistician will provide statistical expertise in support of clinical development. Proactively collaborate with key stakeholders and strategically contribute to project decisions with a focus on study design, analysis, reporting, and proper interpretation and presentation of results.
- Key contributor to study design and analysis of clinical data related to companys development programs.
- Efficiently and effectively coordinate statistical activities for multiple studies, including development of protocols and statistical analysis plans and presentation of results in clinical study reports and other relevant documents.
- Support planning and execution of integrated analyses for regulatory submissions.
- Oversee the work of CROs that are performing statistical activities.
- Program in SAS to summarize results as needed.
- MS or Ph.D. in Statistics, Biostatistics or equivalent required.
- Minimum 5 years of Biostatistics experience in drug-development and clinical research.
- Experience partnering with CROs to manage timelines and deliverables.
- Must be able to explain statistical techniques and considerations to non-statisticians.
- Strong communication skills and the ability to work collaboratively with the clinical project team.
- High attention to detail including ability to manage competing priorities.
- Ability to program using SAS.
- Prior experience with IND/BLA/NDA/MAA submissions.
- Working knowledge of relevant FDA, EMA and ICH guidelines and regulations.
- Must be flexible and work well within a dynamic, interdisciplinary, small company environment requiring multitasking and changing priorities.