As a member of ONO Group
Director, Biostatistics
Location
Massachusetts
Posted
116 days ago
Salary
$200K - $275K / year
Seniority
Lead
Job Description
Director, Biostatistics
Deciphera Pharmaceuticals
• Provide statistical strategy and oversight for multiple clinical studies or programs across all phases of development. • Contribute to Clinical Development Plans and represent Biostatistics on cross-functional teams. • Design studies, author and review protocols and Statistical Analysis Plans (SAPs), and oversee interim and final analysis. • Ensure quality, accuracy, and reproducibility of statistical outputs in collaboration with programming teams and CROs. • Support regulatory submissions (INDs, NDAs, BLAs, MAAs), including health authority interactions and integrated summaries (ISS/ISE). • Provide oversight of external vendors and mentor junior statisticians or contractors. • Contribute to publications, conference presentations, and continuous improvement initiatives.
Job Requirements
- PhD in Statistics (or related field) with 8+ years of clinical trial experience, or MS with 12+ years of experience.
- Deep knowledge of statistical methods for clinical trials and FDA, EMA, and ICH guidelines.
- Proficiency in SAS or R; experience with trial design software (e.g., EAST, nQuery).
- Strong analytical, problem-solving, communication, and influencing skills.
- Ability to manage multiple priorities in a fast-paced environment.
- Preferred Experience supporting NDAs, BLAs, MAAs, and regulatory inspections.
- Experience conducting simulations using SAS, R, or related software.
Benefits
- Competitive salary and annual bonus.
- Comprehensive benefits package including medical, dental, vision insurance, 401(k) retirement plan with company match, and more.
- Generous parental leave and family planning benefits.
- Outstanding culture and opportunities for personal and professional growth.
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