Senior Manager/Associate Director, Biostatistics
Posted on: June 7, 2021
Who we are
REGENXBIO is an exceptional place to work. You'll have the
opportunity to collaborate with some of the best and the brightest
people, touch amazing science, and be a part of extraordinary
plans. Our core values: Trust, Accountability, Perseverance, and
Innovation drive everything we do. We aim to bring these values to
life every day with all that we do, and we believe that what we do
matters - to patients, to their families, and to their
As the Senior Manager/Associate Director of Biostatistics, you
will provide statistical expertise and leadership for clinical
development programs at REGENXBIO, including response to
statistical issues arising from regulatory, research and early
development, and other settings. It will be critical to build
strong collaboration with clinical development and study teams in
order to identify and meet their needs for statistical support.
Additionally, you will be responsible for study design, data
analysis and interpretation of results, and will also provide
statistical strategy and contribute to clinical development plans
and regulatory responses, and other documents. You will also
collaborate with other Biometrics functions at REGENXBIO and in
contract research organization (CRO), as needed.
What you'll be doing
- Lead statistical activities for clinical development programs
and/or gene therapy studies
- Provide statistical expertise in the assigned projects and
- Guide the project teams in using the most efficient or
innovative study design by considering the regulatory agencies'
requirements for the country and regions the compound will be
submitted, and help to maximize the success of the drug
- Serve as a project statistician and ensure the study designs
are scientifically sound and the efficacy and safety information
meets regulatory requirements
- Participate in protocol development and prepare statistical
sections in the protocol, Statistical Analysis Plan (SAP), and
Clinical Data Presentation Plan (CDPP)
- Ensure consistency in data collections, derived data
definitions, analysis file structure, statistical analyses and
result interpretations throughout the drug development
- Lead or participate in the planning and analysis of efficacy
and safety data and ensure that efficacy and safety summaries meet
- Provide input to the entire clinical development plan to ensure
that the overall strategy can deliver the pre-specified target
product profile (TPP) and that proposed studies have appropriate
clinical trial designs
- Research statistical methodologies for rare disease and address
specific statistical issues in the design of clinical studies for
Phase 1 through Phase 4
- Guide CRO biostatistician or statistical programmers, if
necessary, on assigned projects to ensure consistency in derived
data definitions, analysis files structure, analysis methodologies,
and accuracy of analysis results
- Ensure timely delivery of high quality deliverables
- Author documents and responses submitted to health authorities
- It is imperative that REGENXBIO employees embody our core
values by working collaboratively, building strong relationships
and using clear communication to meet shared objectives.
We set our employees up for success. To be successful in this
role and help us achieve our goals, we are looking for someone with
the following skills and qualifications:
- MS or PhD in statistics, biostatistics, or other related field
with high statistical content; PhD preferred.
- Minimum of 7 years, if PhD, of experience working in the
pharmaceutical industry (10 years if MS).
- Knowledge of ICH/EMEMA/FDA guidelines.
- Ability to innovate creatively in a clinical study design
- Ability to communicate with clarity.
- Ability to effectively collaborate and influence other
- Experience working with Statistical Programming and Data
- Demonstrated ability to serve effectively as a team leader
- Experience in regulatory interactions and submissions
- Comprehensive knowledge of statistical methods and applications
in study design and analysis
- Programming skills in SAS (required) and R (preferred)
- Experience in implementation of CDISC, SDTM, and ADaM
- Knowledge of statistical software package such as nQuery, EAST,
Why should you apply?
By joining REGENXBIO, you will have the opportunity to be a part
of a growing company and incredible team passionate about
developing novel AAV gene therapy products to our patients.
We offer a comprehensive and competitive benefit plan which
includes market-competitive salaries, an annual bonus program,
education assistance, retirement plan with employer match, stock
options at all levels, summer hours and more!
In addition, professional development is important to us. By
joining our team, you'll have the opportunity to be exposed to
challenging projects and development resources to help you grow
personally and professionally.
Keywords: REGENXBIO, Rockville , Senior Manager/Associate Director, Biostatistics, Other , Rockville, Maryland
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