Director, Biostatistics - United States - Deciphera Pharmaceuticals

    Deciphera Pharmaceuticals
    Deciphera Pharmaceuticals United States

    2 days ago

    Description
    Company Description
    Job 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
    • 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
    Qualifications
    Qualifications
    • 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
    This is a highly visible role offering the opportunity to shape statistical strategy and directly impact regulatory success and patient outcomes.
    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:
    • 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.
    EQUAL EMPLOYMENT OPPORTUNITY INFORMATION

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Director, biostatistics