Director of Statistical Programming (Immunology)

Employer
AbbVie
Location
Lake County, IL, US
Posted
Aug 09, 2019
Ref
1903015
Discipline
Science/R&D, Immunology
Required Education
Masters Degree/MBA
Position Type
Full time
Purpose:
Candidate is responsible for leading and directing the statistical programming and strategy for all clinical projects within the immunology therapeutic area. You will provide employee development and performance management for staff and assist management in resource estimation and resource management. Candidate will drive efficiencies through innovation and standardization.

Responsibilities:

  • 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.


Level will be based on education & years of experience.

Basic:

  • 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