Associate Director, Biostatistics, Neurology
Company: Jazz Pharmaceuticals
Location: Palo Alto
Posted on: May 16, 2022
Job Description:
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
www.jazzpharmaceuticals.com and follow @JazzPharma on Twitter.The
Associate Director, Biostatistics will function as the statistical
lead on a Jazz Pharmaceuticals drug development project or as the
statistical lead for individual clinical trials, across related
studies, and for integrated summaries and will design and report
Phase I to IV clinical studies and regulatory filings. This
position may have direct reports. This role is responsible for all
statistical aspects of study design, study analysis and validation,
and study documentation. The Associate Director will provide timely
and scientifically sound statistical expertise to clinical
development projects and develop and execute statistical strategy,
design, and analyses for clinical trials. The incumbent will work
collaboratively with clinicians, data managers, other
biostatisticians, and statistical programmers to plan, conduct, and
analyze clinical studies, including integrated reporting. Lead (if
the statistical lead on a clinical development project) or support
(if the statistical lead for individual clinical trials)
statistical input and strategy in governance team discussions.
Contributes to or leads the development of departmental processes
and procedures, including establishing standards and operating
procedures. The Associate Director will manage work done by
statistics and programming external vendors. Oversees professional
development of any direct reports.Essential Functions
- Participate in or lead department and cross-functional meetings
to optimize clinical study designs, endpoints, and analysis
strategies in protocols.
- In conjunction with the project statistical lead, develop and
execute statistical strategy, design, and analyses for clinical
trials
- Develop or review statistical analysis plans and interpret
data.
- Develop statistical programs as necessary to simulate clinical
trial design operating characteristics, perform analysis, prepare
data displays, verify data accuracy and validity of analyses
performed by statistical programming
- Manage CRO statistical activities to ensure timely delivery of
quality analysis results.
- Review and validate CRO deliverables.
- Provide guidelines and standards to CROs to ensure quality
analyses.
- Contribute to or lead Biometrics teams to develop, implement,
and maintain department standards and practices.
- Attend meetings with regulatory agencies; respond to
statistical questions from regulatory agencies.
- Collaborate with researchers and thought leaders to plan
clinical development projects and, if appropriate, publications of
study results.
- Present study results to internal and external audiences
- Be able to conduct independent research and resolve statistical
methodological issues
- Develop statistical programs as necessary to simulate clinical
trial design operating characteristics, perform analysis, prepare
data displays, and verify the correctness of data and
analyses.
- Recruit, develop and supervise internal and external
statisticians.Required Knowledge, Skills, and Abilities
- 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.
- Thorough 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.
- Flexible, positive, creative thinker, good communicator.
- Work without close supervision. Time management skills are
important.Minimum Requirements
- PhD with > 4 years of experience or MS with > 6 years of
experience
- Degree in statistics, mathematics, or a related discipline with
a statistical focus.
- Strong knowledge of clinical trial design, sound understanding
of statistical applications for clinical trials.
- Expert knowledge of drug development regulations pertinent to
statistical analysis.
- Knowledge of the neuroscience therapeutic area is
preferred.
- Bayesian and adaptive design experience is preferred.
- Experience in contributing to NDA or BLA submissions and
defense.
- Proficient SAS programming skills, comprehensive understanding
of CDISC models and standards.
- Excellent writing and communication skills, demonstrated
leadership abilities and excellent interpersonal skillsJazz
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 , Associate Director, Biostatistics, Neurology, Healthcare , Palo Alto, California
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