Sr. Principal Statistician, Biostatistics

Jazz Pharmaceuticals; Philadelphia (Philadelphia County); On-site; USD 156,000 - 234,000; Full time

Benefits offered by this job

Medical, dental and vision insurance

401k retirement plan

Discretionary bonus or incentive plan

Equity grants

Paid vacation

Job summary

Jazz Pharmaceuticals is seeking a Sr. Principal Statistician to lead design, analysis, and reporting across Phase I–IV trials. You will collaborate across functions to shape statistical strategy, oversee external vendors, and support regulatory submissions.

The role requires strong SAS & R skills, CDISC knowledge, and the ability to work with minimal supervision in a fast-paced biopharma environment with US-based candidates.

Qualifications

• MS/MPH in statistics, mathematics, or related field with statistical focus and >4 years in pharma/biotech.
• PhD in statistics, mathematics, or related field with 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.

Responsibilities

• Lead or participate in meetings to optimize study designs and analysis strategies.
• Collaborate with study teams to meet timelines.
• Support development and implementation of study protocols.
• Review data capture systems and participate in validation.
• Develop statistical programs to simulate design and validate analyses.
• Write statistical analysis plans and interpret results.
• Interact with regulatory agencies and respond to queries.
• Monitor CRO guidelines to ensure timely, high-quality deliverables.
• Collaborate with medical writers on clinical reports.

Skills

Statistical design

SAS & R proficiency

Regulatory knowledge

Communication skills

Time management

Education

MS/MPH in statistics

PhD in statistics

Tools

CDISC standards

Statistical programming

Job description

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.

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.

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.

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