Astellas Pharma
Head, Statistical Science, Integrated Oncology (Biostatistics) - Executive Direc
Astellas Pharma, Northbrook, Illinois, us, 60065
Overview
Head, Statistical Science, Integrated Oncology (Biostatistics) - Executive Director at Astellas Pharma. This senior Clinical Biometrics role directs global clinical development statistics for all oncology projects and represents Astellas in interfaces with regulatory agencies globally and in professional societies. Responsibilities
Directs Astellas statistical strategy, creates and organizes new areas of methodological research, and provides best in class data science support to drug development programs. Advise project teams and statistical leads on challenging design, analysis, and decision-making issues. Perform/supervise modeling and simulations; leverage external experts for input to clinical development issues. Provide oversight on statistical matters for meetings with regulatory authorities and key opinion leaders; review key project documents; participate in due diligence; present and defend complex statistical solutions to governance bodies and regulatory bodies. Develop and implement best in class standards, processes, and SOPs in statistics; establish best practices for planning, execution, interpretation, publication, and regulatory submissions of assets. Stay at the cutting edge of methodology development in statistics and oncology drug development; signal relevant developments to the company in a timely manner. Collaborate with cross-functional teams and senior management to address knowledge gaps, tools, and internal skills; support decision making at asset and portfolio levels. Qualifications
PhD or MS in Biostatistics, Statistics or related scientific field. 12+ years (15+ years for MS) of experience in applying statistical methods in biomedical research, Pharma, CRO, Academia or Healthcare, or in providing statistical direction in these areas. Advanced knowledge of statistical methods and industry practices related to clinical data analysis; SAS required, R preferred. Experience in international and matrix environments; broad oncology experience across multiple indications; experience with global submissions and drug development programs. Publication record in clinical trials or methodological research; familiarity with Real World Evidence, omics, digital endpoints, and AI/ML in oncology development. Experience with Bayesian methods, adaptive designs, external/hybrid controls, platform trials, and indirect comparisons. Salary & Benefits
Salary Range: $240K – $305K (final salary based on experience). Working environment includes hybrid options with flexible location in accordance with company guidelines. Benefits include Medical, Dental and Vision Insurance; generous PTO; 401(k) match; life insurance; Corporate Bonus and quarterly incentives; Long Term Incentive Plan; referral programs. Location & Status
This position is based in Northbrook, Illinois with potential remote work in accordance with Responsible Flexibility Guidelines. EOE including Disability/Protected Veterans Category Quantitative Sciences & Evidence Generation Seniority level: Director Employment type: Full-time Job function: Research, Analyst, and Information Technology Industries: Biotechnology Research, Pharmaceutical Manufacturing, and Research Services Referrals increase your chances of interviewing at Astellas Pharma by 2x
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Head, Statistical Science, Integrated Oncology (Biostatistics) - Executive Director at Astellas Pharma. This senior Clinical Biometrics role directs global clinical development statistics for all oncology projects and represents Astellas in interfaces with regulatory agencies globally and in professional societies. Responsibilities
Directs Astellas statistical strategy, creates and organizes new areas of methodological research, and provides best in class data science support to drug development programs. Advise project teams and statistical leads on challenging design, analysis, and decision-making issues. Perform/supervise modeling and simulations; leverage external experts for input to clinical development issues. Provide oversight on statistical matters for meetings with regulatory authorities and key opinion leaders; review key project documents; participate in due diligence; present and defend complex statistical solutions to governance bodies and regulatory bodies. Develop and implement best in class standards, processes, and SOPs in statistics; establish best practices for planning, execution, interpretation, publication, and regulatory submissions of assets. Stay at the cutting edge of methodology development in statistics and oncology drug development; signal relevant developments to the company in a timely manner. Collaborate with cross-functional teams and senior management to address knowledge gaps, tools, and internal skills; support decision making at asset and portfolio levels. Qualifications
PhD or MS in Biostatistics, Statistics or related scientific field. 12+ years (15+ years for MS) of experience in applying statistical methods in biomedical research, Pharma, CRO, Academia or Healthcare, or in providing statistical direction in these areas. Advanced knowledge of statistical methods and industry practices related to clinical data analysis; SAS required, R preferred. Experience in international and matrix environments; broad oncology experience across multiple indications; experience with global submissions and drug development programs. Publication record in clinical trials or methodological research; familiarity with Real World Evidence, omics, digital endpoints, and AI/ML in oncology development. Experience with Bayesian methods, adaptive designs, external/hybrid controls, platform trials, and indirect comparisons. Salary & Benefits
Salary Range: $240K – $305K (final salary based on experience). Working environment includes hybrid options with flexible location in accordance with company guidelines. Benefits include Medical, Dental and Vision Insurance; generous PTO; 401(k) match; life insurance; Corporate Bonus and quarterly incentives; Long Term Incentive Plan; referral programs. Location & Status
This position is based in Northbrook, Illinois with potential remote work in accordance with Responsible Flexibility Guidelines. EOE including Disability/Protected Veterans Category Quantitative Sciences & Evidence Generation Seniority level: Director Employment type: Full-time Job function: Research, Analyst, and Information Technology Industries: Biotechnology Research, Pharmaceutical Manufacturing, and Research Services Referrals increase your chances of interviewing at Astellas Pharma by 2x
#J-18808-Ljbffr