Associate Director Statistical Programming (Hybrid)

The Associate Director provides statistical programming support for multiple clinical projects across multiple therapeutic areas both through individual contribution and through the work of staff. The Associate Director provides 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. The Associate Director is accountable for ensuring statistical programming support is delivered across multiple therapeutic areas. The Associate Director makes key recommendations and decisions related to processes standards and resource management. The Associate Director is also responsible for staff management and development.

Responsibilities:

• SAS Programming: Demonstrates a strong understanding of SAS programming concepts and techniques used in the pharmaceutical industry and applies that knowledge to resolve non-routine problems.
• Standards: Oversees the development and implementation of global company standards for output design and programming conventions and monitors regulatory guidance and industry best practices.
• CRFs and Database Definitions: Provides strategic guidance on CRF and database design and reviews global standards related to these deliverables.
• Derivation Programming Submission Data Sets and Programs: Interprets statistical analysis plans develops analysis data set specifications and oversees the development and implementation of global standards for derived data sets and submission programs.
• Cross-Functional Collaboration: Works collaboratively with stakeholders to manage priorities and resources across therapeutic areas. Demonstrates a solid understanding of drug development principles anticipates risks develops contingency and escalation plans and contributes to cross-functional initiatives.
• Communication: Presents statistical programming concepts risk assessments and recommendations clearly and persuasively to statisticians scientists programmers and non-scientists. Effectively leads meetings and presentations.
• Training and Mentoring: Provides guidance training and mentoring to staff to support development and ensure compliance with training requirements.
• Staff Management: Assigns responsibilities defines scope and reviews progress to ensure projects are delivered on time and with appropriate quality. Allocates resources to maintain the right balance of expertise across projects and collaborates with management to assess staffing needs. Sets high expectations promotes open communication and leads staff to meet organizational goals. Provides performance management for 410 statistical programmers.

Qualifications :

Minimum Qualifications:

• Degree in Statistics Computer Science or a related field 
• 10 years of statistical programming experience (with MS) OR 12 years of statistical programming experience (with BS)
• Strong technical competence in SAS programming and macro development.
• Experience in pharmaceutical clinical trials.
• Experience with regulatory filings such as NDA BLA or other submissions including ISS and ISE experience.

Preferred Qualifications:

• Experience interacting with regulatory agencies especially FDA and EMEA.
• Previous management experience.

Other Required Skills:

• Working knowledge of ICH guidelines and relevant regulatory requirements.
• Strong oral and written communication skills.

Additional Information :

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: 

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location and we may ultimately pay more or less than the posted range. This range may be modified in the future. 

• We offer a comprehensive package of benefits including paid time off (vacation holidays sick) medical/dental/vision insurance and 401(k) to eligible employees.

• This job is eligible to participate in our long-term incentive programs. 

Note: No amount of pay is considered to be wages or compensation until such amount is earned vested and determinable. The amount and availability of any bonus commission incentive benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole and absolute discretion unless and until paid and may be modified at the Companys sole and absolute discretion consistent with applicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. 

US & Puerto Rico only - to learn more visit  & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:

Work :

No

Employment Type :

Full-time