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Jazz Pharmaceuticals jobs

Senior Principal Statistician

$156,000 - 234,000
Jazz Pharmaceuticals
Ratzer Road 1050, Wayne
$156,000 - 234,000
Company Size icon
Company Size
1k-5k
Company Type icon
Company Type
Product
Exp Level icon
Exp Level
Lead
Job Type icon
Job Type
Full-Time
Language icon
Language
English
Visa sponsorship icon
Visa sponsorship
No

Requirements

Must:
- MS or MPH in statistics, mathematics, or a related discipline with a statistical focus and over 4 years of experience in the pharmaceutical or biotechnology industry. - PhD in statistics, mathematics, or a related discipline with a statistical focus and over 2 years of experience in the pharmaceutical or biotechnology industry. - Comprehensive understanding of clinical trial design and analysis, including complex statistical methods and models. - Proficiency in using SAS and R, with additional knowledge of other statistical applications being advantageous. - Familiarity with applicable regulatory requirements and guidelines, such as ICH Guidelines and drug development standards as they pertain to statistics. - Capability to thrive in a dynamic, team-oriented environment. - Exceptional written and verbal communication skills. - Strong attention to detail to ensure the quality completion of studies. - Flexible, creative thinker with good communication skills. - Ability to work independently and effectively manage time.

Technologies

Marketing
SAS

Responsibilities

- Lead statistical aspects of study design and analysis for Phase I to IV clinical studies and regulatory filings. - Participate in departmental and cross-functional meetings to enhance clinical study designs and analysis strategies. - Collaborate with team members to adhere to study timelines and develop as well as implement study protocols. - Review and provide feedback on data capture systems and participate in their validation. - Create statistical programs to simulate clinical trial design characteristics, perform analyses, and validate the accuracy of outputs from statistical programming. - Draft and review statistical analysis plans, oversee data analysis, and interpret results. - Prepare for and attend meetings with regulatory authorities. - Work alongside biostatistics leads and peers to establish and uphold departmental standards and practices. - Review timelines and analysis plans for contract research organization (CRO) work to ensure quality and timely delivery. - Validate CRO deliverables and act as a statistical subject matter expert in documentation processes with medical writers and colleagues. - Address statistical inquiries from regulatory agencies.

Description


At Jazz Pharmaceuticals, we are a global biopharma company driven by the mission to innovate and improve the lives of patients and their families. We specialize in creating transformative medicines for serious diseases, focusing on those with limited therapeutic options. With a diverse portfolio including treatments for sleep disorders, epilepsy, and an expanding range of cancer therapies, our science-driven approach fuels innovative research across multiple therapeutic areas. We are headquartered in Dublin, Ireland, with R&D labs and manufacturing facilities worldwide. We are dedicated to excellence and offer competitive compensation packages, including a comprehensive benefits program and a commitment to diversity and equal opportunity.
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