Deciphera Pharmaceuticals
201 - 500 employees
Founded 2016
🧬 Biotechnology
💊 Pharmaceuticals
Biotechnology • Pharmaceuticals
Deciphera Pharmaceuticals is a biotechnology company dedicated to defeating cancer by developing innovative kinase inhibitors to improve patient outcomes. The company focuses on designing switch-control kinase inhibitors to address mechanisms of tumor and drug resistance, aiming to enhance treatment responses for patients with cancer. Deciphera has a diverse pipeline of drug candidates, including ripretinib and vimseltinib, and is committed to making a significant impact on the lives of cancer patients. As of June 2024, Deciphera is a wholly-owned subsidiary of ONO Pharma and continues to work on improving human health through its scientific innovations and patient-centric approach.
Director, Biostatistics
🕒 February 25
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Deciphera Pharmaceuticals
201 - 500 employees
Founded 2016
🧬 Biotechnology
💊 Pharmaceuticals
Biotechnology • Pharmaceuticals
Deciphera Pharmaceuticals is a biotechnology company dedicated to defeating cancer by developing innovative kinase inhibitors to improve patient outcomes. The company focuses on designing switch-control kinase inhibitors to address mechanisms of tumor and drug resistance, aiming to enhance treatment responses for patients with cancer. Deciphera has a diverse pipeline of drug candidates, including ripretinib and vimseltinib, and is committed to making a significant impact on the lives of cancer patients. As of June 2024, Deciphera is a wholly-owned subsidiary of ONO Pharma and continues to work on improving human health through its scientific innovations and patient-centric approach.
📋 Description
• 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.
🎯 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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