Associate Director – Biostatistics

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🔥 0 minutes ago

🏄 California, Pennsylvania – Remote

🏄 California – Remote 🔔 Pennsylvania – Remote

💵 $172k - $258k / year

⏰ Full Time

🟠 Senior

👔 Director

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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Jazz Pharmaceuticals

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2003

🏥 Healthcare

🏭 Manufacturing

🧬 Biotechnology

Healthcare • Manufacturing • Biotechnology

Jazz Pharmaceuticals is a biopharmaceutical company dedicated to developing innovative medicines that address serious unmet medical needs. With a strong commitment to research and development, Jazz focuses on creating life-changing therapies, emphasizing the importance of collaboration, diversity, and employee engagement in its operations. The company prides itself on transforming patients' lives through its meaningful product offerings and a culture that fosters enthusiasm and flexibility.

📋 Description

• Function as statistical lead on a Jazz Pharmaceuticals drug development project or individual clinical trials • Design and report Phase I to IV clinical studies and regulatory filings • Own statistical aspects of study design, analysis, validation, and documentation • Develop and execute statistical strategy, design, and analyses for clinical trials • Collaborate with clinicians, data managers, biostatisticians, and statistical programmers • Lead or support statistical input and strategy in governance team discussions • Contribute to or lead departmental processes, procedures, standards, and operating procedures • Manage work performed by external statistics and programming vendors • Oversee professional development of direct reports • Participate in or lead department and cross-functional meetings to optimize study designs, endpoints, and analysis strategies • Develop or review statistical analysis plans and interpret data • Develop statistical programs to simulate clinical trial operating characteristics, perform analyses, prepare data displays, and verify data accuracy and analysis validity • Contribute to or lead Biometrics teams in developing, implementing, and maintaining standards and practices • Attend regulatory agency meetings and respond to statistical questions • Collaborate with researchers and thought leaders on clinical development projects and publications • Present study results to internal and external audiences • Conduct independent research and resolve statistical methodological issues • Recruit, develop, and supervise internal and external statisticians

🎯 Requirements

• PhD with > 4 years of experience or MS with > 6 years of experience • Degree in statistics, mathematics, or a related discipline with a statistical focus • Knowledge of clinical trial design and analysis, including complex statistical methods and models • Good knowledge and experience working in Oncology therapeutic area • Experience using SAS or R • Thorough knowledge of applicable regulatory requirements and guidelines, including ICH Guidelines • Knowledge of CDISC SDTM and ADaM standards • Experience contributing to NDA or BLA submissions and defense • Proficient SAS programming skills • Comprehensive understanding of CDISC models and standards • Excellent writing and communication skills • Demonstrated leadership abilities and excellent interpersonal skills • Experience with Bayesian and adaptive designs preferred • Knowledge of oncology or hematology therapeutic area preferred

🏖️ Benefits

• Discretionary annual cash bonus or incentive compensation • Discretionary equity grants • Medical insurance • Dental insurance • Vision insurance • 401k retirement savings plan • Flexible paid vacation