Role based in Barcelona - 3 days at office / 2 days at home
This is what you will do:
The Epidemiology
and
Real World
Science (Epi
RWS) team is a growing group within the Alexion-
AstraZenca
Rare Disease Unit which is driving the scientific use of
Real World
Data to accelerate the way that patients access innovative medicines
.
The
Epidemiologist
is a scientific role that involves
supporting the
development
and
execution of
impactful
epidemiological
deliverables
that deepen our understanding of
rare diseases, with a focus on Alexion’s
clinical development programs and post-marketing studies
.
The
role
involves
working closely with other Epidemiologists
and Real
World
Data
Scientists
in the department
to
support
the development
, execution, interpretation and communication
of scientifically robust stage-appropriate evidence
that enhances decision-making across the portfolio
,
such as
:
conducting literature reviews
;
characterizing
incidence and prevalence to
support regulatory and safety
documents
;
critically appraising & synthesizing relevant literature; analysis of real-world databases; describing patient characteristics, natural history, treatment patterns and outcomes; quantification of event rates and phenotypic / genotypic traits or associations; and landscaping for suitable data-sources.
This role involves
supporting
engagements
with
colleagues across the company
,
including:
Clinical Development,
Global
Patient Safety, Regulatory Affairs, Global Medical Affairs, and Global Marketing
.
The Epidemiologist may
participate
in cross-functional teams and sub-team meetings, under the guidance of
senior members of the
Epi
RWS department when
appropriate
.
The
Epidemiologist
must have mature team-working behaviors with organizational awareness and insight
.
The ideal candidate will have experience with analysis and interpretation of epidemiologic data within the context of rare disease
s
and
a passion for applying epidemiology to support life-transforming therapies
for patients.
You will
be responsible for
:
Support
ing the
planning
, development
,
and execution of
E
pidemiology deliverables
, with a focus on
Alexion’s
clinical development programs and post-marketing studies
, including:
conducting literature reviews,
characterizing
incidence and prevalence
to support regulatory and safety documents
; critically appraising & synthesizing relevant literature; analysis of real-world databases; describing patient characteristics, natural history, treatment patterns and outcomes; quantification of event rates and phenotypic / genotypic traits or associations; and landscaping for suitable data-sources
.
Provid
ing
epidemiology
support
into study protocols
, analysis plans
,
and regulatory documents.
Summarizing
results
in written reports and oral presentations
.
May
participate
in cross-functional team meetings
and
supporting
the
presentation of summary findings to Alexion internal/external stakeholders.
Maintain
ing
awareness of epidemiology with respect to regulatory requirements, payer trends, and advancement of pharmacoepidemiology methods.
Travel may be