Senior Principal Statistician, Biostatistics
28 days ago
Cambridge
Join Our Team at Jazz Pharmaceuticals!\n If you're a current Jazz employee, we invite you to apply through our Internal Career site. \n About Us: Jazz Pharmaceuticals is a global biopharma company dedicated to transforming the lives of patients and their families. Our mission is to develop life-changing medicines for individuals facing serious diseases, often with limited or no therapeutic options. With a diverse portfolio that includes leading therapies for sleep disorders, epilepsy, and a growing range of cancer treatments, we are committed to pioneering research and development in oncology and neuroscience. Headquartered in Dublin, Ireland, we have a global presence with research labs, manufacturing facilities, and dedicated employees working tirelessly to serve patients worldwide. Position Overview\n We are seeking a Senior Principal Statistician to lead statistical efforts across clinical studies, from Phase I to IV, and regulatory filings. In this role, you will be responsible for all statistical aspects of study design, analysis, validation, and documentation. Your Responsibilities\n\n • Participate in department and cross-functional meetings to enhance clinical study designs and analysis strategies.\n, • Collaborate with team members to meet study timelines and support protocol development.\n, • Review and validate data capture systems and contribute to their implementation.\n, • Develop statistical programs for clinical trial simulations, data displays, and analysis verification.\n, • Write and review statistical analysis plans, oversee data analysis, and interpret results.\n, • Prepare for and attend meetings with regulatory agencies.\n, • Work with biostatistics leads to maintain department standards and practices.\n, • Review timelines and deliverables from CROs to ensure quality and timeliness.\n, • Act as a statistical expert in the production of clinical reports and integrated summaries.\n, • Respond to statistical inquiries from regulatory agencies.\nWhat You Bring\n\n, • Knowledge & Skills: Strong understanding of clinical trial design, complex statistical methods, and regulatory guidelines (e.g., ICH Guidelines).\n, • Technical Proficiency: Experience with SAS and R; familiarity with other statistical applications is a plus.\n, • Interpersonal Skills: Excellent communication skills, both written and verbal, with a keen attention to detail.\n, • Work Ethic: Ability to thrive in a fast-paced, flexible, team-oriented environment.\nEducation & Experience\n\n, • MS or MPH in statistics, mathematics, or a related discipline with over 4 years of experience in the pharmaceutical or biotechnology industry.\n, • PhD in statistics, mathematics, or a related discipline with over 2 years of relevant experience.\n, • Preferred knowledge in oncology or hematology therapeutic areas, with Bayesian and adaptive design experience.\n, • Proficient in SAS & R programming, with a solid understanding of CDISC models and standards.\nWhy Jazz?\n At Jazz Pharmaceuticals, we believe in fostering a supportive and inclusive work environment. As a valued member of our team, you will enjoy: \n\n • Comprehensive medical, dental, and vision insurance.\n, • A robust retirement savings plan.\n, • Flexible paid vacation to recharge and rejuvenate.\n, • Opportunities for professional growth and development.\n\n Join us in our mission to make a difference in the lives of patients. We look forward to welcoming you to our team! \n Jazz Pharmaceuticals is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.