🛠 Tech Stack

💼 About This Role

You'll lead statistical aspects of clinical projects at a clinical-stage biotech targeting CNS disorders. Your work will directly impact regulatory submissions and publications.

🎯 What You'll Do

• Provide sample size/power calculations and author statistical sections of protocols.
• Develop SAPs and table/figure/listing shells, overseeing CRO work.
• Collaborate with cross-functional teams to meet project deliverables.
• Provide statistical input for regulatory interactions and documents.

📋 Requirements

• PhD in biostatistics with 7+ years or Master's with 10+ years in pharma/biotech.
• Experience in clinical trial design, analysis, and reporting.
• Knowledge of FDA, EMA, and ICH regulations for clinical trials.
• Proficient in SAS and R.

✨ Nice to Have

• Familiarity with CNS endpoints and associated analysis methodologies.
• Experience with trial design software (e.g., EAST).
• Understanding of SDTM and ADaM data standards.

🎁 Benefits & Perks

• 💰 Annual bonus opportunity
• 🏥 Medical, dental, vision, life, AD&D
• 🏖️ Flexible non-accrual paid time off
• 👶 Parental leave
• 📈 401(K) plan with match and stock options

📨 Hiring Process

Estimated timeline: 2-4 weeks · AI estimate

1. 1Recruiter Screen· 30 min
2. 2Hiring Manager Interview· 45 min
3. 3Technical Interview· 60 min