- 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
- 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
- Experience supporting NDAs, BLAs, MAAs, and regulatory inspections
- Experience conducting simulations using SAS, R, or related software
- 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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Director, Biostatistics - United States - Deciphera Pharmaceuticals
Description
Company DescriptionJob Description
We are seeking an experienced Director, Biostatistics to serve as Study Statistician across one or more drug development programs. This individual will provide statistical strategy from early development through regulatory submission, partnering cross-functionally to drive data-informed decision-making and ensure scientific and regulatory excellence.
Key Responsibilities
Qualifications
Additional Information
Deciphera is committed to fair and equitable compensation practices. The base salary pay range for this role is $200,000 - $275,000. Actual compensation packages will depend on various factors, including, but not limited to depth of experience, education, skillset, overall performance and/or location.
Deciphera believes in providing a competitive compensation and benefits package to all employees. Our base salary is just one component of Deciphera's competitive total rewards strategy that also includes annual performance bonus, a long-term incentive plan, full range of benefits and other incentive compensation plans (if applicable)
Benefits:
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Associate Director, Biostatistics
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Associate Director, Biostatistics
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Executive Director/VP, Biostatistics
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Director of Scientific Analytics
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Senior Director
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Director of Scientific Analytics
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Biostatistician
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Associate Director, IT
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Healthcare Research Analytics Internship
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