Job Details
About the Opportunity:
You will have the opportunity to lead biostatistics activities for innovative clinical trials, contributing to the development of cutting-edge treatments for various diseases. Join our collaborative team of experts to drive statistical strategies and analyses, ensuring the integrity and accuracy of clinical trial data. Work in a dynamic environment where your contributions will directly impact the advancement of new therapies, ultimately benefiting patients worldwide. Our client is strategically located across the U.S., offering opportunities for collaboration with professionals from diverse backgrounds.
Responsibilities:
- Provide statistical and operational input for study and program design, protocol sections, statistical analysis plans (SAP), clinical study reports (CSR), regulatory documents, and scientific publications.
- Evaluate alternative methods of study design and analysis.
- Assist in establishing departmental standards, processes, and training.
- Ensure statistical integrity of key deliverables throughout the drug development process.
- Offer scientifically sound methodology for study design and data analysis in line with regulatory guidance and industry standards.
- Collaborate with programming and data management to ensure accurate data collection and reporting.
- Oversee statistical and programming deliverables by CROs.
- Assist in identifying and selecting service providers.
Requirements:
- PhD in Biostatistics or related field with 5+ years of experience in pharmaceutical or biotechnology drug development.
- Experience with various aspects of clinical development, including regulatory submission and post-approval activities.
- Proficiency in SAS and R; familiarity with East and Spotfire.
- Excellent verbal and written communication skills.
- Knowledge of pharmaceutical clinical development processes.
- Understanding of regulatory guidelines related to dataset submission and SDTM/ADaM specifications.
Preferred:
- Familiarity with CDISC guidelines.
Additional Information:
- This is an onsite role.
- A relocation package will be offered.
- Reporting into the VP of Biostatistics.
- Pay Range (California): $130,000 $180,000 USD