Associate Director, Statistical Programming
Company: AbbVie, Inc.
Posted on: June 10, 2021
Associate Director, Statistical Programming
- Irvine, United States of America; Sunnyvale, United States of
America; Madison, United States of America; Lake County, United
States of America
- Research and Development
AbbVies mission is to discover and deliver innovative medicines
that solve serious health issues today and address the medical
challenges of tomorrow. We strive to have a remarkable impact on
peoples lives across several key therapeutic areas: immunology,
oncology, neuroscience, eye care, virology, womens health and
gastroenterology, in addition to products and services across its
Allergan Aesthetics portfolio. For more information about AbbVie,
please visit us at www.abbvie.com . Follow @abbvie on Twitter ,
Facebook , Instagram , YouTube and LinkedIn .
Provide statistical programming support for multiple clinical
projects across multiple therapeutic areas through own effort and
those of their staff. Provide training and performance management
for staff.The Senior Manager demonstrates leadership competencies,
builds relationships and promotes teamwork within the statistical
programming organization and across functions. Accountable for
providing Statistical Programming support for multiple therapeutic
areas. Responsible for making key recommendations and decisions
related to processes, standards and resource management.
Responsible for management and development of staff.
- SAS Programming: Demonstrated extensive understanding of SAS
programming concepts and techniques appropriate to the
pharmaceutical industry. Demonstrated proficiency in applying SAS
programming knowledge to solve problems related to non-routine
situations. Standards: Oversees effort to determine and implement
global company standards related to output design and programming
conventions. Responsible for monitoring regulatory guidance and
industry best practices.
- Case report forms and database definitions: Provides strategic
guidance on the development of CRFs and database designs.
in-depth critical review of global standards related to CRF designs
and database designs. Derivation Programming, Submission Data Sets
and Programs: Demonstrated proficiency in interpreting statistical
analysis plans and developing analysis data set
- Oversees effort to determine and implement global company
standards related to derive data sets and subm
- Works collaboratively with multiple stakeholders to manage
priorities and resources across therapeutic areas.
- Demonstrates an understanding of drug development principles.
Anticipates potential problems within and across projects and
appropriate contingency plans. Creates escalation plans to ensure
resolution of all issues at the therapeutic and project
- Participates in and is viewed as a key contributor to cross
- Effectively and persuasively presents statistical programming
concepts, assessment of risks and impacts and logical
arguments to other statistical programmers, statisticians,
scientists and non-scientists.
- Effectively presents information through planning and execution
of meetings and presentations.
- Training and Mentoring: Provides appropriate background and
motivation to staff. Arranges appropriate training opportunities
for staff to
facilitate their timely career development.
- Ensures that self and staff are compliant with training
requirements. Effectively mentors statistical programming staff
with regard to functional operations.
- Manages statistical programming staff by appropriate assignment
of responsibilities, defining scope and reviewing
activities/progress so that projects are delivered on time with
- Allocates resources to projects such that the correct balance
of expertise and experience is maintained for all projects. Works
collaboratively with the statistical programming management team to
assess project resource requirements versus current staff
- Establishes high expectations and goals to ensure
organizational success and leads staff to meet or exceed those
goals. Creates an organization that executes efficiently and is
committed to meeting goals. Encourages a culture of open, honest
communication where all are encouraged to express their views.
Provide all performance management activities for 4-10 statistical
- MS in Statistics, Computer Science or a related field with 10+
years of relevant experience. OR BS in Statistics, Computer Science
related field with 12+ years of relevant experience.
- High degree of technical competence and communication ability,
both oral and written. Highly competent in SAS programming and
development. Pharmaceutical experience with clinical trials,
including familiarity with expectations of regulatory agencies,
especially FDA and EMEA. NDA/BLA or other regulatory filing
experience, including ISS or ISE experience. Thorough understanding
of ICH Guidelines and
relevant regulatory requirements. A minimum of 2 yrs management
Significant Work Activities
Yes, 5 % of the Time
Job Level Code
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse
backgrounds to develop new and innovative solutions for patients.
As an equal opportunity employer we do not discriminate on the
basis of race, color, religion, national origin, age, sex
(including pregnancy), physical or mental disability, medical
condition, genetic information gender identity or expression,
sexual orientation, marital status, protected veteran status, or
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Keywords: AbbVie, Inc., Sunnyvale , Associate Director, Statistical Programming, Other , Sunnyvale, California
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