Director, Oncology Statistics - Remote
Company: Jazz Pharmaceuticals
Location: Palo Alto
Posted on: November 22, 2022
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 on Twitter. The Director, Biostatistics is the statistical lead
on one or more 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 clinical studies in all
phases, including integrated reporting. Oversees professional
development of biostatisticians.Essential Functions
- Lead drug development project(s) by developing and executing
statistical strategy, design, and analyses for clinical
- Manage biostatisticians within the drug development
- Manage CROs providing statistical support to ensure timely
delivery of quality analysis results; oversee contracts and
- Approve guidelines and standards of CROs to ensure quality of
- 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
- 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
- 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,
including statistical principles and methodology and principles of
statistical inference, including hypothesis testing and deriving
estimates, parametric and non-parametric models and techniques,
principles of sample size calculations for comparing two arms,
principles of design of experiments in introducing conditions
designed to affect an outcome of interest, and phase II-IV clinical
trial data analysis.
- 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
- Able to work in a fast-paced, flexible, team-oriented
- Possess excellent interpersonal and communication skills
(written and verbal).
- Strong attention to detail with a view to bring studies to a
- 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
- Expert knowledge of drug development regulations pertinent to
- Knowledge of the oncology therapeutic area is preferred.
- Bayesian and adaptive design experience.
- Experience in contributing to NDA or BLA submissions and
defense is required.
- 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
- 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.
Keywords: Jazz Pharmaceuticals, Palo Alto , Director, Oncology Statistics - Remote, Executive , Palo Alto, California
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