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The Senior Principal Statistician will lead statistical aspects of Phase I to IV clinical studies, including study design, analysis, and regulatory documentation. They will collaborate with cross-functional teams and manage external vendors to ensure scientifically sound and timely delivery of clinical trial results.
Requirements
Candidates must hold an MS, MPH, or PhD in statistics or a related discipline with several years of pharmaceutical industry experience. Proficiency in SAS and R, along with a strong understanding of clinical trial regulations and CDISC standards, is required.
Full job description
If you are a current Jazz employee please apply via the Internal Career site
Jazz Pharmaceuticals 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.
Job Description
Brief Description:
The Senior Principal Statistician, Biostatistics will be a lead statistician on individual studies, across related 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 all 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 develop 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.
Develop statistical programs as necessary to simulate clinical trial design operating characteristics, perform 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, perform and oversee data analysis and validation, and interpret analyses.
Prepare for and attend meetings with regulatory agencies.
Work with biostatistics compound/therapeutic area lead, peer management, and employees to develop, 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 complex 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 affect an outcome of interest, and phase II-IV clinical trial data analysis.
Experience in using SAS 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 close supervision. Well-developed time management skills are important.
Required/Preferred Education and Licenses
MS or MPH in statistics, mathematics, or a related discipline with a statistical focus and > 4 years of experience in pharmaceutical or biotechnology industry.
PhD in statistics, mathematics, or a related 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 SAS & R programming skills, solid understanding of CDISC models and standards.
Excellent writing and communication skills, demonstrated leadership abilities and excellent interpersonal skills.
#LI-Remote
Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and 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.
FOR US BASED CANDIDATES ONLY
Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the full and complete base pay range is:
$156,000.00 - $234,000.00
Individual compensation paid within 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 aligned with the candidate's expertise and contributions, within the established pay framework and our Total Compensation philosophy. Internal equity considerations will also influence individual base pay decisions. This range will be reviewed on a regular basis.
At Jazz, your base 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
Related keywords
BiostatisticsClinical trialsSASRCDISCOncologyHematologyRegulatory affairsPhase I-IVStatistical analysis planPharmacovigilanceData managementBayesianAdaptive designBiopharmaClinical development
Jazz Pharmaceuticals plc (Nasdaq: JAZZ), is a global biopharmaceutical company whose purpose is to innovate to transform the lives of patients and their families. We are focused on developing life-changing medicines for people with rare diseases—often with limited or no options—so they can live their lives more fully. By transforming biopharmaceutical discoveries into novel medicines, we are working to give people around the world the opportunity to redefine what’s possible – to make the “small wins” big again.
Founded in 2003, we maintain a highly collaborative culture where employees focus on how they can be successful and accomplish positive results by exemplifying the company’s core values: integrity, collaboration, passion, innovation and the pursuit of excellence.
Together, we are experts, analysts, specialists, advocates, scientists and professionals all with diverse backgrounds and perspectives. Working together, we are proud to support patients, innovate and bring new medicines to patients with critical unmet needs in rare disease.
Please see our website at www.jazzpharma.com for more information. For information on recruitment, please visit https://careers.jazzpharma.com/. For guidelines on engaging with Jazz on social media, please visit https://bit.ly/2OaMOuq.
Offices: Waterloo Exchange, Waterloo Road, Dublin, 4, IE · 2005 Market St, Philadelphia, Pennsylvania 19103, US · 3170 Porter Dr, Palo Alto, California 94304, US · Oxford Business Park South, Oxford, England OX4 2, GB · 250-887 Great Northern Way, Vancouver, British Columbia V5T 4T5, CA
Biopharmaceuticalinnovationresearch and developmentgreat place to workepilepsysleep disordersoncologyand rare diseaseHealth CareBiotechnology
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