(Senior)Director, Biostatistician

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.