Director of Statistical Programming (Safety Statistics) (Oswego)

AbbVie in Oswego, IL

  • Industry: Scientific Research - Statistics
  • Type: Full Time
  • $103,055.00 - 195,330.00
position filled
Purpose:

Candidate will be responsible for leading and directing the statistical programming strategy for safety statistical programming across all therapeutic areas through own effort and those of their staff. You will provide training and performance management for staff and assist management in resource estimation and resource management.

Responsibilities:
  • SAS Programming: Demonstrated extensive understanding of SAS programming concepts and techniques appropriate to the pharmaceutical industry. Able to critically review programming techniques and strategy. Recognizes limitations in programming strategy and corrects flaws proactively.
  • Standards: Monitors and interprets industry/regulatory trends and regulatory guidance. Sets both short and long term vision for programming standards. Ensures programming standards work seamless with related function's standards.
  • Database Activities:Case report forms and database definitions: Provides strategic guidance on the development of CRFs and database designs. Provides strategic guidance on 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 specifications. Monitors and interprets industry/regulatory trends and regulatory guidance. Sets both short and long term vision for programming standards
  • Client Interaction: Works collaboratively with multiple stakeholders to manage priorities and resources across therapeutic areas. Builds relationships with external partners and service organizations. Demonstrates an understanding of 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 levels. Provides strategic guidance and is bu
  • Communication: 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 coaching and mentoring to first line managers when needed. Provides strong professional and technical leadership to maintain highly motivated staff. Arranges appropriate training opportunities for staff to facilitate their timely career development.Ensures consistency of training opportunities across the organization. Ensures that self and staff are compliant with training requirements.
  • Resource Management: Manages statistical programming staff by appropriate assignment of responsibilities, defining scope and reviewing activities/progress so that projects are delivered on time with suitable quality.Allocates resources to projects such that the correct balance of expertise and experience is maintained for all projects. Responsible for assisting the Global Director of Statistical Programming in preparing global resource planning.
  • 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.


Level will be based on education & years of experience.

Basic:
  • MS in Statistics, Computer Science or a related field with 12+ years of relevant experience OR BS in Statistics, Computer Science or related field with 14+ years of relevant experience.
  • High degree of technical competence and communication ability, both oral and written. Highly competent in SAS programming and Macrodevelopment. 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 5 years of management experience is required.

Associated topics: ad, endowment, facebook, government, hospital, major gift, media, policy, policies, relationship

You may be interested in these similar jobs!
Senior Statistician, Research (Hoffman Estates)
AbbVie in Hoffman Estates, IL

Purpose: The Senior Research Statistician, Statistics is responsible for providing statistical support to the research and development organization…

Read More
Senior Research Statistician/ Manager, Statistics (Schaumburg)
AbbVie in Schaumburg, IL

Introduction: The Senior Research Statistician/ Manager, Statistics is responsible for providing statistical support to the research and developmen…

Read More
Statistical Programmer (Bolingbrook)
AbbVie in Bolingbrook, IL

Responsibilities Accountable for their assigned work or supportive quality control in the programming space supporting a particular project, study o…

Read More
Data Scientist (Elgin)
AbbVie in Elgin, IL

The Data Scientist II will work for OBI (Operation Business Insight) organization and will be responsible to deliver business analytics capabilities …

Read More
Principal/ Sr. Principal Research Statistician, Statistical Innovation (Elmhurst)
AbbVie in Elmhurst, IL

Overview: The Senior Principal Research Statistician in Statistical Innovation is responsible for providing scientific, statistical and strategic l…

Read More
Biostatistician/ II- phase 1 home-based opportunity (Hoffman Estates)
Pharmaceutical Product Development in Hoffman Estates, IL

*LI-KF1#GDPPD s mission is to improve health.It starts as an idea to cure. It becomes a lifesaved. All in-between, it s you!We know that meaningful r…

Read More
Clinical Data Analyst (Lockport)
AbbVie in Lockport, IL

Introduction: AbbVie Data Science is the best-in-class team within its cross-industry peer group and is responsible for bringing people, process, a…

Read More
Architect, Technology II (La Grange)
AbbVie in La Grange, IL

Effectively function as a principle architect, generating new technological proposals and leading those efforts. Anticipate and critically evaluate …

Read More
Principal Biostatistician - Oncology Trials / Pharma
Cytel in Naperville, IL

Join us in playing an important part in helping our clients drive healthcare forward and ultimately improve human health outcomes! Cytel provides unr…

Read More
Entry Level Machine Operator (Elgin)
Herrmann Ultraschall in Elgin, IL

Job Description We are searching for a Machine Operator with ability to work with attention to detail and safety standards. Based in our Bartlett-IL …

Read More