Jazz Pharmaceuticals is an international biopharmaceutical company focused on improving patients' lives by identifying, developing and commercializing meaningful products that address unmet medical needs. We are continuing to expand our commercial product portfolio and our research and development pipeline in therapeutic areas that can leverage our unique expertise.
Our therapeutic areas of focus include sleep and hematology/oncology - areas in which we have a deep understanding of the patient journey and a suite of products and product candidates to address critical needs.
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 Director, Biostatistics will act as the statistical expert and overall statistical leader providing oversight and strategic input for the entire therapeutic area. This position will have direct reports up to Director level, will participate in critical regulatory interactions, will provide statistical leadership on molecule/therapeutic area level as appropriate, will be accountable for biostatistics deliverable, and will ensure consistency of strategy from statistical perspectives across therapeutic area.
- Lead the biostatistics function and personnel to develop and execute statistical strategy, design, and analyses for clinical trials within the therapeutic area.
- Manage a team of biostatisticians within the therapeutic area.
- Work with department head, peer management, and employees to develop, implement, and maintain department standards and practices
- Provide statistical and drug development expertise in collaborations with researchers and thought leaders, in the planning of clinical development programs.
- Support statisticians in ensuring timely delivery of quality analysis results using internal resources and CRO vendors.
- Attend meetings with regulatory agencies and support/defend clinical programs
- Present study results to internal and external audiences
- Be able to conduct independent research and resolve statistical methodological issues
- Recruit, develop, and supervise internal and external statistical resources to achieve department functional and company goals
Required Knowledge, Skills, and Abilities
- A minimum of 10 years of experience with at least 3 years of supervisory experience is preferred
- Good knowledge of drug development regulations pertinent to statistical analysis
- Experience in providing statistical leadership to NDAs/BLAs submission, supporting review, and experience in regulatory interactions is required
- Proficient in SAS, solid understanding of CDISC models and standards
- Excellent writing and communication skills, demonstrated leadership abilities and excellent interpersonal skills
Required/Preferred Education and Licenses
- PhD in Statistics, Mathematics, or related fields
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.