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Job
Description:
The
Associate Director Statistics - Medical
Affairs will perform
all or some of the following Job
description:
-
The
Associate Director Statistics -
Medical Affairs will actively
provide statistical support to the
Medical Affairs Department
-
Provide statistical support for
publications, presentations, posters
at medical meetings and any other
requests not covered in the clinical
study report. This includes data
mining, meta-analysis, and support
for data-driven analyses
-
The
Associate Director Statistics -
Medical Affairs will interact with
authors, referees and in-house
reviewers in the preparation of
publications, presentation and
posters
-
Provide statistical reviews of
proposed design and analysis of
protocols
-
Provide in-house technical advice on
current advances in statistical
methodology
-
The
Associate Director Statistics -
Medical Affairs will determine the
most efficient way of performing the
analyses balancing between in-house
resources and outside CROs
-
Perform “hand’s on” analyses as
required
-
Accurately assess in-house support
needs
-
The
Associate
Director Statistics - Medical
Affairs will
supervise in-house support personnel
Contribute to new SOPs/WPs
Contribute to the creation,
maintenance, and expansion of
standard validated computer programs
The
Associate Director Statistics -
Medical Affairs will
provide training on statistical
topics and on SOPs/WPs
He/She will
serve
as the statistical representative in
the defense of the company’s
statistical position/approach in the
drug approval process globally
Provide statistical input to senior
management
The
Associate Director Statistics -
Medical Affairs will
manage outside CROs and consultants
as needed
Work
closely with other departments in
the company (regulatory, clinical,
marketing, data management, health
economics, etc.) and provide
statistical support for a variety of
functional groups.
Minimum Requirements / Knowledge /
Skill For Associate Director Statistics
- Medical Affairs Job
-
The
Associate Director Statistics -
Medical Affairs should have
excellent written and oral
communication skills
-
Interpersonal communication and
organizational skills
-
Experience in oncology is an added
advantage
-
The
Associate Director Statistics -
Medical Affairs should
demonstrate skill in the planning,
analysis and reporting of clinical
trials
-
He/She should have
detailed knowledge of statistical
methodologies and statistical
regulatory requirements
-
Previous experience in leading and
completing a task force and/or
supervising statisticians
-
The
Associate Director Statistics -
Medical Affairs should have
up-to-date knowledge of clinical
trial design concepts
-
In-depth knowledge of all phases of
the drug development process
-
The
Associate Director Statistics -
Medical Affairs must
demonstrate ability to work in a
team environment with clinical team
members
-
He/She should have
up-to-date knowledge of statistical
development methodologies and
optimal methodologies acceptable to
regulatory agencies.
Minimum Education Requirements /
Certification / Licensure For
Associate Director Statistics - Medical
Affairs Job
-
Completed Ph.D. in Statistics with
8+ years pharmaceutical experience
as a statistician supporting
clinical trials.
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