Employer Industry: Biotechnology

Why Consider this Job Opportunity:
- Salary up to $218,160
- Opportunity for career advancement and growth within the organization
- Flexible remote work options available
- Supportive and collaborative work environment
- Chance to contribute to innovative cancer treatment and make a positive impact on patient lives

What to Expect (Job Responsibilities):
- Act as the lead statistician for designated compounds/indications, ensuring consistency in statistical methods across trials
- Provide statistical input to clinical development strategies and trial designs
- Engage with regulatory authorities for discussions related to compounds and trials
- Coordinate data transfers and ensure adherence to statistical standards and documentation
- Participate in cross-functional teams and represent biostatistics in various meetings

What is Required (Qualifications):
- Master's or PhD in a statistical discipline with 8+ years of experience in a relevant technical area
- Proven experience in statistical analysis, modeling, simulation, and adaptive trial designs
- Familiarity with FDA, EMA, and ICH guidance for drug development pertaining to statistics
- Experience with regulatory submissions including BLAs and knowledge of SDTM, ADaM, eSUB, and CDISC requirements
- Demonstrated ability to manage multiple complex projects/studies in a technical capacity

How to Stand Out (Preferred Qualifications):
- Experience in drug development for biologics, targeted therapies, and companion diagnostics
- Proven track record of effective collaboration in a fast-growing, dynamic company
- Strong desire to work in a mission-driven environment focused on innovative cancer treatments

#Biotechnology #ClinicalDevelopment #StatisticalAnalysis #RemoteWork #CareerOpportunity

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