Job Details
Company Address:
CA, United States
Address: South San Francisco, CA 94080, USA.
Maryland, United States
Address: Rockville, MD 20850, USA.
KEY RESPONSIBILITIES
- Strategic Leadership: Provide strategic guidance as the expert in statistics, data science, programming, and data management for global clinical development.
- Clinical Development and Regulatory Interaction: Offer biostatistical input for overall clinical development strategies, protocol design, statistical analysis plans, and regulatory interactions. Handle briefing books, submissions, and address requests and positions from regulatory agencies.
- Global Clinical Studies Management: Plan, monitor, and analyze global clinical studies. Coordinate the development and review of statistical aspects of regulatory submissions.
- Vendor Management: Manage and oversee biostatistical, programming, and data management aspects of vendors, including CROs, IRT, eCOA, etc.
- Cross-Functional Collaboration: Work closely with global medical, clinical operations, regulatory, and safety teams to ensure efficient execution of global clinical trials.
- Statistical Analysis Execution: Oversee global statistical analyses, including tables, listings, and figures. Prepare statistical methods and results for study reports and contribute to data interpretation and decision-making processes.
- Data Collection and Design Support: Provide guidance on data collection, design, and analysis for global studies. Ensure efficient medical and safety data review and monitoring.
- IDMC Activities Management: Manage blinded and unblinded Independent Data Monitoring Committee (IDMC) activities, from strategy development to generation of Trial Listing Files (TLFs).
- Methodological and Regulatory Standards Maintenance: Keep up-to-date with statistical methods, industry standards, and regulatory requirements.
- Clinical Study Documentation Preparation: Prepare clinical study documents for eCTD clinical modules. Familiarity with CDISC standards, IWRS, ADaM Specs, and review define documents.
- Molecule Development and Commercialization Support: Contribute statistical expertise to support molecule development and commercialization strategies, including post hoc analyses and interpretation of results.
REQUIREMENTS
Education:
- Master's degree in Biostatistics, Statistics, or related filed required.
- Ph.D. in related field, preferred.
Experience:
- At least 10 years' experience, responsible for biostatistics of clinical trials.
- Experience collaborating with scientific teams to design robust experiments and clinical trials.
- Demonstrated experience applying statistical theories and methods to solve complex biological problems.
- Experience using statistical software such as R, SAS, or SPSS for data analysis and modeling.
- Familiarity with complex statistical methods that apply to applicable clinical trials.
Skills:
- Strong analytical thinking and problem-solving abilities.
- Ability to handle multiple projects simultaneously.
- Excellent written and verbal communication skills.
- Ability to work cross-functionally in a fast-paced, collaborative environment.
- Strong attention to detail.
OTHER
Supervisory Responsibilities:None.
Equipment To Be Used:Laptop computer, other office equipment, and/or lab equipment.
Typical Physical Demands:Manual dexterity sufficient to operate standard office equipment.
Working Conditions:Works remotely or in the office. Occasionally called upon to work hours in excess of your normal daily schedule. Requires up to 10% travel as needed.
COMPENSATION & BENEFITS
Benefits:
- 401(k) and matching program
- Medical, Vision, and Dental Insurance
- Flexible Spending Account
- Short- and long-term disability
- Life insurance
- Employee Assistance Program
- Employee discounts
- Paid time off/vacation/sick time
- Professional development assistance
- Referral program