Purpose :

Describes the primary goals,objective or function or outputs of this position.

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 Associate Director 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 :

List up to 10 main responsibilities for the job. Include information about the accountability and scope

• 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 :

List required and preferred qualifications up to 10). Include education, skills and experience.

• 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.

AbbVie is an equal opportunity employer including disability/vets. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because 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, status as a disabled veteran, recently separated veteran, Armed Forces service medal veteran or active duty wartime or campaign badge veteran or a person’s relationship or association with a protected veteran, including spouses and other family members, or any other protected group status. We will take affirmative action to employ and advance in employment qualified minorities, women, individuals with a disability, disabled veterans, recently separated veterans, Armed Forces service medal veterans or active-duty wartime or campaign badge veterans. The Affirmative Action Plan is available for viewing in the Human Resources office during regular business hours.