Senior Principal Statistician, Biostatistics (Remote)
Company: Disability Solutions
Location: Harrisburg
Posted on: April 19, 2024
Job Description:
If you are a Jazz employee please apply via the Internal Career
siteJazz 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.
Brief Description:The Senior Principal Statistician, Biostatistics
will be a lead statistician on individual studies, across related
studies, and for integrated summaries and will design and report
Phase I to IV clinical studies and regulatory filings under the
supervision of a more senior statistician. This role is responsible
for all statistical aspects of study design, study analysis and
validation, and study documentation. The Senior Principal
Statistician will provide timely and scientifically sound
statistical expertise to clinical development projects and develop
and execute statistical strategy, design, and analyses for clinical
trials. This position will work collaboratively with clinical
development, pharmacology, pharmacovigilance, clinical drug supply,
project management, regulatory affairs, medical writing, clinical
data management, and clinical operations. The Senior Principal
Statistician will manage work done by statistics and programming
external vendors.Essential Functions
- Participate in department and cross-functional meetings to
optimize clinical study designs, endpoints, and analysis strategies
in protocols.
- Collaborate with cross-functional team members to meet study
any recurring report timelines.
- Support the development and implementation of study
protocols.
- Review and provide input to data capture systems and
participate in their validation.
- 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.
- Write statistical analysis plans, review statistical analysis
plans written by other statisticians, perform and oversee data
analysis and validation, and interpret analyses.
- Prepare for and attend meetings with regulatory agencies.
- Work with biostatistics compound/therapeutic area lead, peer
management, and employees to develop, implement, and maintain
department standards and practices.
- Review timelines and analysis plans for CRO work to ensure
timeliness and quality deliveries.
- Review and validate CRO deliverables.
- Act as the statistical subject matter expert with medical
writers and other colleagues in the production of clinical reports,
integrated summaries, and other documents.
- Respond to statistical questions from regulatory
agencies.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 and R; knowledge of other statistical
applications and programming languages a plus.
- 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 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.Required/Preferred Education and Licenses
- MS or MPH in statistics, mathematics, or a related discipline
with a statistical focus and > 4 years of experience in
pharmaceutical or biotechnology industry.
- PhD in statistics, mathematics, or a related discipline with a
statistical focus and > 2 years of experience in the
pharmaceutical or biotechnology industry.
- Knowledge of drug development regulations pertinent to
statistical analysis.
- Knowledge of the oncology or hematology therapeutic area is
preferred
- Bayesian and adaptive design experience is preferred.
- Proficient SAS & R programming skills, 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 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 anticipated base pay range is $148,000-$194,250. The
exact base pay offered for this role will depend on various
factors, including but not limited to the candidate's
qualifications, skills, and experience.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, Harrisburg , Senior Principal Statistician, Biostatistics (Remote), Other , Harrisburg, Pennsylvania
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