The Johnson and Johnson Medical
Device (MD) Sector Clinical Research and Development Center of Excellence
(CR&D COE) is recruiting for a Lead Biostatistician. The preferred location
is Raynham MA, however we are also open to our West Chester, PA, or Warsaw, IN
The MD CR&D COE is being
created to support all clinical activities across all business units within the
Johnson & Johnson Medical Device companies. The COE organization is
based on three functional teams: Franchise, Operations and Biostatistics &
Data Management. All three teams share accountability for the successful
development and delivery of clinical evidence globally to internal and external
stakeholders that drives innovation in surgical solutions and that optimizes
the product lifecycle. Each team within CR&D COE will have primary
responsibility for defined areas of clinical program development, execution and
The Lead Biostatistician will be
responsible for leading statistical and analytical services in support of
clinical trials, regulatory submissions, marketing efforts, and quality
initiatives, as well as providing guidance on standards, processes, and
technical topics within the statistics team.
His/her work will follow guidance from Biostatistics management, and
will adhere to applicable regulations for pre- and post- market clinical
trials. S/he ensures statistical analyses are conducted with the highest level
of scientific integrity, while meeting timelines and budgets. Reporting to the
guidance on standards, processes, and technical direction within the
with Biostatistics, Data Management, Regulatory, and Clinical staff to define
and clarify project requirements.
and execute statistical plans independently for all phases of clinical studies,
assuming a leadership role in creating strategy for study design and analyses.
clinical study protocols and Case Report Forms (CRFs) for proposed studies with
respect to statistical methodology.
generation of randomization schemes; supervise unblinding of treatment
assignments and appropriate handling of unblinded information.
the review and assessment of protocol deviations to the extent that they affect
statistical reports that may be incorporated into internal clinical reports or
to peer-reviewed articles independently, in coordination with the lead
articles on topics relevant to specified products and provide reports
concerning issues relating to statistical methodology.
with preparation of documentation for IRB/Ethics Committee submissions.
as a statistical consultant to the business units and external customers on
in vendor evaluation, selection, contracting, and oversight for statistical and
statistical reports for data quality/performance metrics.
Clinical Research with literature reviews and other activities.
assist in presenting information at professional meetings.
oversee the statistical deliverables produced by lower-level biostatisticians
or external consultants.
oversee production of presentation materials for presentations at professional
current with statistical methodology in clinical trial design and analysis.
in the preparation and documentation of results to support trial reports and
Master’s degree in Statistics, Biostatistics, or Applied Statistics with at
least 6 years of experience OR a Ph.D. with at least 4 years of experience
performing statistical analyses in a regulated environment, preferably
medically related is required.
of US law, regulations, and FDA guidance covering good clinical practice (GCP)
technical experience in preparing statistical deliverables on time is required.
understanding of descriptive statistics, power/sample size analysis, hypothesis
testing, non-parametric, and multivariate statistical tests is required.
to assist in selecting and applying statistical methods in the field of
application is required.
with survival analysis, longitudinal data analysis, and other current
statistical methodologies is required.
verbal and written communication skills are required.
in SAS and Microsoft software (Word, Excel, PowerPoint) is required.
and willingness to travel up to 10% is required.
with other statistical packages and power analysis software is required.
of Bayesian statistics, meta-analyses, or simulation techniques is required.
to contribute to strategic planning is preferred.
United States-Massachusetts-RaynhamOther Locations
North America-United States-Pennsylvania-West Chester, North America-United States-Indiana-WarsawOrganization
Depuy Orthopaedics. Inc. (6029)Job Function