Job Information
Jazz Pharmaceuticals, Inc. Senior Director, Biostatistics in Palo Alto, California
Senior Director, Biostatistics
Biostatistics
Palo Alto,
California
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The Senior Director, Biostatistics will act as the statistical expert and overall statistical leader providing oversight and strategic input for the entire sleep 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 sleep therapeutic area.
Essential Functions
Lead the biostatistics function and personnel to develop and execute statistical strategy, design, and analyses for clinical trials within sleep therapeutic area.
Manage a team of biostatisticians within the sleep 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
Minimum Requirements
PhD in Statistics, Mathematics, or related fields;
A minimum of 10 years of experience with at least 5 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
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 statu