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 www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Purpose: The Associate Director Statistical Programming Oncology Early Development (OED) is a key member of the Data Management and Analysis team. This individual provides statistical programming and analysis oversight for OED clinical projects conducted by CROs. The Associate Director demonstrate leadership competencies, builds relationships and promotes collaboration across functions with internal colleagues. This individual is responsible for making key recommendations and decisions related to CRO SOW, processes, standards and resource allocation. This individual works to ensure data integrity for oncology first in human clinical trials up through clinical proof of concept. Responsibilities:  Manage CROs and other outside vendors for statistical programming activities for OED clinical trials as appropriate in relation to clinical trial data analysis needs.  Oversees CRO SAS programming by defining and reviewing scope and providing ongoing review of activities and progress to ensure projects are delivered by the CROs on time with suitable quality.  Provides CROs with input into the development of CRFs and database designs, and definitions.  Oversees CRO effort related to derive data sets, submission data sets and programs, and analysis data set specifications. Oversee the CRO development of SAS programs for the creation of ADaM data sets following CDISC standards for OED clinical trials and allowing for integrated data at AbbVie. Oversee the CRO development of SAS programs for the creation of Tables, Listings and Figures for OED clinical trials.  Ensure that appropriate concepts and techniques relevant to the pharmaceutical industry are implemented for OED clinical trials. Responsible for monitoring regulatory guidance and industry best practices related to output design and programming conventions to allow for a seamless transition of work internally for programs that meet cPOC.  Works collaboratively with multiple stakeholders, anticipates potential problems within and across projects and develops appropriate contingency plans.  Effectively and persuasively represent statistical programming to cross functional team members. Effectively present statistical programming concepts, risk assessments and impact, and logical arguments to cross functional colleagues in OED.  May be responsible for managing statistical programming staff and allocating project resource assignments. 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. .  CRO oversight and vendor management experience preferred. Significant Work Activities N/A Travel No 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.