Jazz Pharmaceuticals is a global biopharmaceutical company dedicated to developing life-changing medicines for people with serious diseases - often with limited or no options. We have a diverse portfolio of marketed medicines and novel product candidates, from early- to late-stage development, in key therapeutic areas. Our focus is in neuroscience, including sleep medicine and movement disorders, and in oncology, including hematologic and solid tumors. We actively explore new options for patients including novel compounds, small molecule advancements, biologics and innovative delivery technologies. Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in more than 90 countries.
We are looking for the best and brightest talent to join our team. If you're looking to be a part of a company with an unwavering commitment to improving patients' lives and being a great place to work, we hope you'll explore our career openings and get to know Jazz Pharmaceuticals.
The Senior Manager, Biostatistics will be functioning as a statistical lead on Jazz Pharmaceuticals clinical development projects. This position will work collaboratively with clinicians, data managers, biostatisticians, and statistical programmers in the planning, conduct, and analysis of clinical studies in all phases.Essential Functions
- Provide timely and scientifically sound statistical expertise to clinical development projects and develop/execute statistical strategy, design, and analyses for clinical trials
- Work with biostatistics compound/therapeutic area lead, peer management, and employees to develop, implement, and maintain department standards and practices
- Develop/write statistical analysis plans and provide data interpretation.
- Develop statistical programs as necessary to perform analysis, prepare data displays, verify data accuracy and validity of analyses performed by statistical programming
- Collaborate with members of project teams to establish project timelines and to develop and implement protocols
- Help design data capture methods and select appropriate study endpoints for clinical programs
- Manage CROs regarding statistical activities to ensure timely delivery of quality analysis results
- Provide guidelines and standards to CROs to ensure quality of deliverables
- Respond to statistical questions from regulatory agencies
- PhD or Master's Degree in Statistics, Mathematics, or related fields
- A minimum of 5 years of experience in pharmaceutical or biotechnology industry is required
- Strong knowledge of clinical trial design, sound understanding of statistical applications for clinical trials
- Good knowledge of drug development regulations pertinent to statistical analysis
- Experience in contributing to NDAs/BLAs submission
- Proficient SAS programming skills, solid understanding of CDISC models and standards
- Excellent writing and communication skills, and demonstrated interpersonal skills
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.