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Associate Director, Statistical Programming

Company: AbbVie
Location: North Chicago
Posted on: May 3, 2021

Job Description:

About AbbVie 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 Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Purpose: 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. Responsibilities: 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. Provides 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 specifications. 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 develops appropriate contingency plans. Creates escalation plans to ensure resolution of all issues at the therapeutic and project levels. Participates in and is viewed as a key contributor to cross functional initiatives. 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 suitable quality. 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 programmers Qualifications Qualifications: MS in Statistics, Computer Science or a related field with 10+ years of relevant experience. OR BS in Statistics, Computer Science or a 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 Macro 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 experience required. Significant Work Activities N/A Travel Yes, 5 % of the Time Job Type Experienced Schedule Full-time Job Level Code M 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.

Keywords: AbbVie, Waukegan , Associate Director, Statistical Programming, Other , North Chicago, Illinois

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