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Director, Biostatistics

Company: Disability Solutions
Location: Sacramento
Posted on: July 9, 2024

Job Description:

If you are a current Jazz employee please apply via the Internal Career site.Jazz Pharmaceuticals plc (NASDAQ: JAZZ) is a global biopharmaceutical 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 and novel product candidates, from early- to late-stage development, in neuroscience and oncology. We actively explore new options for patients including novel compounds, small molecules and biologics, and through cannabinoid science and innovative delivery technologies. Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in nearly 75 countries. For more information, please visit and follow @JazzPharma on Twitter. Brief Description: The Director, Oncology Early Development Biostatistics is the statistical lead on Oncology Early Development Jazz Pharmaceuticals drug development projects, and will act as a statistical expert across all studies in the project(s). This position can have direct reports up to Associate Director level, participates in regulatory interactions for the project(s), provides statistical leadership for direct reports, and ensures the quality and timeliness of biostatistics analyses. Contributes to or leads development of departmental processes and procedures, including establishing standards and operating procedures. Lead statistical input and strategy in governance team discussions. This position works collaboratively with clinicians, data managers, other biostatisticians, and statistical programmers in the planning, conduct, and analysis of early phase oncology clinical studies. Oversees professional development of biostatisticians.Essential Functions

  • Lead early phase oncology drug development projects by developing and executing statistical strategy, design, and analyses for clinical trials.
  • Manage biostatisticians within the drug development projects.
  • Manage CROs providing statistical support to ensure timely delivery of quality analysis results; oversee contracts and invoices.
  • Approve guidelines and standards of CROs to ensure quality of deliverables.
  • Contribute to or lead Biometrics teams to develop, implement, and maintain department standards and practices.
  • Provide technical support and input to project statisticians and statistical tasks.
  • Provide statistical expertise to prepare for meetings with regulatory agencies; attend meetings with regulatory agencies; respond to statistical questions from regulatory agencies and support and defend clinical programs.
  • Collaborate with researchers and thought leaders in the planning of clinical development programs and the publication of study data.
  • Present study results to internal and external audiences.
  • Develop statistical programs as necessary to simulate clinical trial design operating characteristics, simulate clinical trial design operating characteristics, perform analysis, prepare data displays, and verify the correctness of data and analyses.
  • Be able to conduct independent research and resolve statistical methodological issues.
  • Recruit, develop, and supervise internal and external statisticians to achieve project goals.
  • May lead outsourcing statistical activities within a program.Required Knowledge, Skills, and Abilities
    • Expert knowledge of clinical trial design and analysis, including experience with complex statistical methods and models.
    • Experience in using SAS or R; knowledge of other statistical applications and programming languages a plus.
    • Expert knowledge of applicable regulatory requirements and guidelines, e.g., ICH Guidelines and drug development regulatory requirements as they relate to statistics, including statistical contributions to marketing applications and CDISC SDTM and ADaM standards.
    • 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.
    • Work without close supervision. Well-developed time management skills are important.Minimum Requirements
      • PhD or MS degree in statistics, mathematics, or a related discipline with a statistical focus.
      • A minimum of 8 years of experience; supervisory experience is preferred.
      • Expert knowledge of statistical designs of early phase oncology studies
      • Expert knowledge of drug development regulations pertinent to statistical analysis.
      • Bayesian Phase I and Phase II oncology study design experience.
      • Knowledge of clinical pharmacology and translational science preferred.
      • Experience in contributing to IND submissions and defense is required.
      • Experience with NDA or BLA submissions preferred.
      • Proficient SAS programming skills, solid 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 ONLYJazz 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: $196,000.00 - $294,000.00Individual 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: .

Keywords: Disability Solutions, Sacramento , Director, Biostatistics, Executive , Sacramento, California

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