Director, Statistical Programming (Medical Aesthetics)
AbbVie's 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 people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's 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 .
This position is functionally aligned and dedicated to support the Aesthetics R&D and is responsible for leading and directing the statistical programming and reporting strategy for the Medical Aesthetics (MA) therapy area, including device research. The key responsibilities also include driving efficiencies through innovation and standardization, building and leading a team of high performing staff with specific knowledge of aesthetics and device research areas, managing internal and external budget and resources. Medical Aesthetics being a recent addition to AbbVie portfolio, this role has an additional responsibility for coming 2-3 years to ensure smooth integration of legacy Allergan resources, processes, and systems to retain and enhance knowledge base to ensure future success.
- SAS Programming: Demonstrated extensive understanding of SAS programming concepts and techniques, with expertise in programming techniques for the pharmaceutical industry. Able to critically review programming techniques and strategy. Recognizes limitations in programming strategy and corrects flaws proactively.
- Standards: Lead the development of standards for statistical output and analysis data sets. Monitors and interprets industry/regulatory trends and regulatory guidance. Sets both short term and long term vision for programming standards.
- Derivation Programming, Submission Data Sets and programs: Demonstrated proficiency in interpreting statistical analysis plans with extensive knowledge of efficacy endpoints for the designated therapeutic area. Proficiency in reviewing analysis data set specifications. Monitors and interprets industry/regulatory trends and regulatory guidance related to the therapeutic area.
- Client Interaction: Works collaboratively with multiple stakeholders to manage priorities and resources across the therapeutic area. Builds relationships with external partners and service organizations. Demonstrates expertise in the therapeutic area and in the drug development principles. Anticipates potential problems within and across projects and develops appropriate contingency plans. Creates escalation plans to ensure resolution of all issues at the therapeutic and project level.
- Communication: Effectively and persuasively presents statistical programming concepts, assessment of risks, impact and logical arguments to programmers and non-programmers. Effectively presents information through planning and execution of meetings and presentations. Able to effectively present material to the Development Leadership.
- Employee Development: Provides coaching and mentoring to first line managers and effectively implements employee development plans for staff. Provides strong professional and technical leadership to maintain highly motivated staff.
- Resource Management: Allocates resources to projects within the therapeutic area to ensure projects can be executed per the development plan. Responsible for assisting the Senior Director of Statistical Programming in global resource planning.
- Establishes high expectations and goals to ensure organizational success and leads staff to meet or exceed those goals. Creates and motivates organization that executes efficiently and is committed to meeting goals. Encourages a culture of innovation with open, honest communication where all are encouraged to express their views.
- MS in Statistics, Computer Science or related field with 14+ years of relevant experience. OR BS in Statistics, Computer Science or related field with 16+ years of relevant experience.
- High degree of technical competence and communication ability, both oral and written. Highly competent in SAS programming and Macro Development. Extensive pharmaceutical experience, including experience with regulatory agency expectations through multiple regulatory filing. Extensive experience with FDA and EMA filings including ISS, ISE and advisory committee experience.
- Minimum of 8 years of management experience required.
Significant Work Activities
Yes, 20 % 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 any other legally protected characteristic.