Sr. Principal Statistician, Biostatistics

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Job Description

The Sr. Principal Statistician, Biostatistics will be a lead statistician supporting the design and reporting of Phase I to IV clinical studies and regulatory filings under the supervision of a more senior statistician. This role is responsible for the statistical aspects of study design, study analysis and validation, and study documentation. The Principal Statistician will provide timely and scientifically sound statistical expertise to clinical trials 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 Principal Statistician will oversee work done by statistics and programming external vendors. Essential Functions

• Participate in or lead department and cross-functional meetings to optimize clinical study designs, endpoints, and analysis strategies.
• Work collaboratively with members of study teams to meet study and recurring report timelines.
• Support the development and implementation of study protocols.
• Review and provide input to study-specific 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, perform data analysis and validation, and interpret analyses.
• Support project lead statistician.
• Prepare for and attend meetings with regulatory agencies.
• Respond to statistical questions from regulatory agencies.
• Work closely with statistical programming colleagues.
• Monitor CRO guidelines and standards to ensure timeliness and quality of deliverables.
• Review and validate CRO deliverables.
• Other work as assigned by line manager.
• Collaborate as the statistical subject matter expert with medical writers in the production of clinical reports, integrated summaries, and other documents.
• Learn drug development regulatory requirements as they relate to statistics, including statistical contributions to marketing applications and CDISC SDTM and ADaM standards.
• Stay current with new developments in statistics, drug development, and regulatory guidance through literature review, conference attendance, and other professional development activities.

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.
• 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.
• Be able to work without close supervision with effective time management.

Minimum Requirements

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

Description of Physical Demands

• Occasional mobility within office environment.
• Routinely sitting for extended periods.
• Constantly operating a computer, printer, telephone, and other similar office machinery.

Description of Work Environment

• Works indoors in normal office environment with little exposure to excessive noise, dust, fumes, and temperature changes.
• Computer use at a workstation.
• May move from one work location to another occasionally.
• Responsibilities may require a work schedule that may include working outside of normal work hours, in order to meet business demands.
• Occasional public contact requiring appropriate business apparel.

#Li - Remote 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 Apply tot his job Apply To this Job