Sponsor Oncology client is looking for a remote Sr/Principal level Biostatistician for their growing team!
- Responsible for oversite of the clinical trial study design and development of statistical analysis plans (SAP)
- Leads coordination of functional teams to develop custom data models, algorithms, and monitor outcomes.
- May perform data review & statistical analyses; coordinate/oversee statistical outputs
- Provide input on EDC system development including but not limited to database design, CRF design, validation checks & key data
- Leads internal and external partners to establish, align and confirm data management expectations
- Responsible for the development and writing of statistical sections for integrated reports and statistical reports
- May review clinical data management documents (including submission package) ensuring appropriate quality, scientific content, organization, clarity, accuracy, format and consistency.
- Ensures content and integration requirements for eCRF and other data collection tools are met.
- Ensure conventions and quality expectations for clinical data are maintained for dataset content and structure
- Ensure the proper execution of SAS programming deliverables
- Understand and apply regulatory guidelines/developments and industry standards/best practices on statistics and SAS programming
- Maintain statistical, clinical, and therapeutic acumen in clinical research through education, programs, lectures and publications
Qualifications (Education & Experience):
· Minimum of 5 years of experience in statistics in a CRO/Pharma setting
· Master's or PHD in statistics or biostatistics.
· Excellent knowledge of RAVE, CDISC and SAS under FDA/EMA requirement
· Excellent written and verbal communication skills for coordinating across teams.
· Oncology experience a plus!