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An Individual Contributor role
Productive
ands on
programming, supporting deliverables in the study / project / portfolio / standards team, of
medium - high
complex statistical programming deliverables
to support assets and study teams
Performs tasks
independently
with mentorship or advise from Programming Leads within the organization
Acts as co-lead / lead on selected projects / initiatives /
activities
and also
study deliverables as needed.
Guide, mentor,
monitor
programmers within the team and collaborate with S
DS
L's on timelines, resource
management
and
deliverables with quality.
Is capable of handling standards / study programming specific activities independently including collaboration across
stakeholders at various
timezones
Ensures adherence to
high quality
programming standards in their daily work
Ensure the tasks are completed on time with quality and are compliant to the process at Pfizer with needed guidance.
Work collaboratively with study teams and stakeholders such as clinicians and statisticians on milestones and deliverables.
Active self-learning and delivering on solutions in the space of statistical programming and data standards
Contribute to
SDSA
initiatives globally and locally.
Accountable for
multiple projects / ongoing work activities (timelines, work plans, deliverables) of moderate complexity within a Work Team
Accountable for their assigned work supporting the standards /
tudy deliverables
and also
to
assist
DS
L's with the team assignments.
Review /
Develop /
Validate
/ Review
datasets, TFL as per CDISC aligned Pfizer Standards or Pfizer Data Standards for Study / Project / Portfoli
o. (Portfolio)
Contributes
to
upto
0% of their time to
programming deliverables assigned within the scope of the function in either SAS, R or Python
and 20% to
self learning
development
and growth
Explore the existing code base and execute / perform runs as
required
, also develop /
modify
as per the needs and specifications suggested to the standards team as
appropriate -
(Standards Programming)
Ensures
appropriate documentation
and QC across the lifespan of the study for
all of
their
programming deliverables
across Standards, Programming and Submissions.
Understand
/ Implement
standard / study / project / portfolio requirements
and specification and work with global stakeholders in ensuring completion of project / study / deliverable goals and milestones
Knowledgeable in core safety standards as well as TA standards pertinent to their project and lead development of standards necessary for their study
Exhibits routine and occasionally complex
problem solving
skills, seeking direction when
appropriate
Regularly update leads on progress and time estimations to ensure smooth daily operations and
accurate
planning
Support in accomplishing department and organization mission by completing assigned tasks
Acts as mentor to junior team members
Advances job knowledge to next level by
participating
/ contributing in / to opportunities both globally and locally.
QUALIFICATIONS
/ SKILLS
Bachelor or Master (preferred) Degree in Statistics,
Computer Sciences, Engineering,
Pharmacy, b
iological
ciences, IT, or related field.
At least
5 - 6
years relevant experience in a pharmaceutical, biotech, CRO, or Regulatory Agency.
Understanding
of clinical data and drug development process
, CDISC standards
required
Statistical Programming and SAS hand-on experience
Clinical trials
expertise
with an understanding of data operations required for the reporting of clinical
Good understanding of ICH and regulatory guidelines
Working knowledge of clinical data and relevant data standards
Is able to
work with stakeholders across
timezones
under tight timelines
Strong written and oral communication skills, and time
and project
management skills
Strong competencies and interests for innovation and problem solving
Proven ability to
operate
with limited oversight
Knowledge of at least 1 Therapeutic Area
Work Location Assignment : Flexible
Work Location Assignment : Hybrid
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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