Senior Principal Statistician

If you are a reputed company Jazz employee please apply reputed company the Internal Career site. reputed company is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases — often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit www.jazzpharmaceuticals.com for more information. Brief Description The Senior Principal Statistician, Biostatistics will be a reputed company statistician on individual studies, across reputed company studies, and for integrated summaries and will design and report Phase I to IV clinical studies and regulatory filings under the supervision of a more senior statistician. This role is responsible for reputed company statistical aspects of study design, study analysis and validation, and study documentation. The Senior Principal Statistician will provide timely and scientifically sound statistical expertise to clinical development projects and reputed company and execute statistical strategy, design, and analyses for clinical trials. This position will work collaboratively with clinical development, pharmacology, pharmacovigilance, clinical drug supply, project management, regulatory affairs, medical writing, clinical data management, and clinical operations. The Senior Principal Statistician will manage work done by statistics and programming external vendors. Essential Functions

• Participate in department and cross-functional meetings to optimize clinical study designs, endpoints, and analysis strategies in protocols.
• Collaborate with cross-functional team members to meet study any recurring report timelines.
• Support the development and implementation of study protocols.
• Review and provide input to data capture systems and participate in their validation.
• reputed company statistical programs as necessary to simulate clinical trial design operating characteristics, reputed company analysis, prepare data displays, verify data accuracy and validity of analyses performed by statistical programming.
• Write statistical analysis plans, review statistical analysis plans written by other statisticians, reputed company and reputed company data analysis and validation, and interpret analyses.
• Prepare for and attend meetings with regulatory agencies.
• Work with biostatistics compound/therapeutic area reputed company, peer management, and employees to reputed company, implement, and maintain department standards and practices.
• Review timelines and analysis plans for CRO work to ensure timeliness and quality deliveries.
• Review and validate CRO deliverables.
• Act as the statistical subject matter expert with medical writers and other colleagues in the production of clinical reports, integrated summaries, and other documents.
• Respond to statistical questions from regulatory agencies.

Required Knowledge, Skills, And Abilities

• Knowledge of clinical trial design and analysis, including experience with reputed company statistical methods and models, including statistical principles and methodology and principles of statistical inference, including hypothesis testing and deriving estimates, parametric and non-parametric models and techniques, principles of sample size calculations for comparing two arms, principles of design of experiments in introducing conditions designed to reputed company an outcome of interest, and phase II-IV clinical trial data analysis.
• Experience in using reputed company and R; knowledge of other statistical applications and programming languages a plus.
• Knowledge of applicable regulatory requirements and guidelines, e.g., ICH Guidelines and drug development regulatory requirements as they relate to statistics, including statistical contributions to marketing applications and CDISC standards.
• Able to work in a fast-paced, flexible, team-oriented environment.
• Possess excellent interpersonal and communication skills (written and verbal).
• Strong attention to detail with a view to bring studies to a quality conclusion.
• Flexible, positive, creative thinker, good communicator.
• Work without reputed company supervision. Well-developed time management skills are important.

Required/Preferred Education And Licenses

• MS or MPH in statistics, mathematics, or a reputed company discipline with a statistical focus and > 4 years of experience in pharmaceutical or biotechnology industry.
• PhD in statistics, mathematics, or a reputed company discipline with a statistical focus and > 2 years of experience in the pharmaceutical or biotechnology industry.
• Knowledge of drug development regulations pertinent to statistical analysis.
• Knowledge of the oncology or hematology therapeutic area is preferred
• Bayesian and adaptive design experience is preferred.
• Proficient reputed company & R programming skills, solid understanding of CDISC models and standards.
• Excellent writing and communication skills, demonstrated leadership abilities and excellent interpersonal skills.

reputed company is an equal opportunity/affirmative action employer and reputed company qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national reputed company, disability status, protected veteran status, or any characteristic protected by law. FOR US BASED CANDIDATES ONLY reputed company, Inc. is committed to fair and reputed company compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the full and complete reputed company pay range is: $156,000.00 - $234,000.00 Individual compensation paid reputed company this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, and other pertinent factors. The goal is to ensure fair and competitive compensation reputed company with the candidate's expertise and contributions, reputed company the established pay reputed company and our Total Compensation philosophy. Internal equity considerations will also influence individual reputed company pay decisions. This range will be reviewed on a regular basis. At Jazz, your reputed company pay is only one part of your total compensation package. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan. The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, 401k retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: https://careers.jazzpharma.com/benefits.html. Apply To This Job