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Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions 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, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Job Description

Role Overview

The Manager of Statistical Programming is a leadership role which manages a team of statistical programmers in the research and development of new pharmaceutical products. The Senior Manager of Statistical Programming is responsible for leading the statistical programming activities for one or more compounds/indications or a therapeutic area. This role must effectively interface with Statistics, Clinical Data Management, Medical Writing, Regulatory Publishing and Clinical Operations.

Key Responsibilities

• Collaborate with statisticians to develop, review, and approve Statistical Programming Plans (SPP). Implement Statistical Analysis Plans (SAP) and SPP to create ADaM data specifications.

• Program and validate ADaM and statistical analyses using programming languages (e.g., SAS, R), ensuring adherence to established standards and guidelines.

• Generate tables, listings, and figures (TLFs) for clinical study reports, safety reports, and other deliverables, ensuring accuracy, consistency, and adherence to regulatory requirements.

• Develop and maintain programming documentation, such as annotated program code, programming specifications, and validation plans.

• Perform quality control checks on statistical programming deliverables to ensure accuracy, consistency, and adherence to programming standards.

• Collaborate with cross-functional teams to support ad hoc data analyses, data visualization, and exploratory analyses as needed.

• Ability to lead the development and implementation of standard programming macros, utilities, and tools to improve efficiency and consistency in programming tasks.

• Stay updated with industry best practices, regulatory guidelines, and emerging technologies in statistical programming and data analysis.

• Lead the planning and execution of statistical programming-related audits, inspections, and regulatory submissions, ensuring compliance with relevant regulations and guidelines.

• Collaborate with statisticians and study teams to provide programming support, address data-related queries, and contribute to study-related publications.

Qualifications

Education/Experience

• Master's degree with 6+ years of experience or Bachelor’s degree with 8+ years of experience in statistics, computer science, engineering, or a related field.

• Understanding of statistical methods, data analysis techniques, and clinical research processes.

• Proficiency in programming languages commonly used in statistical programming, such as SAS or R.

• Knowledge of CDISC standards.

• In-depth understating of drug development process with emphasis on clinical study life cycle.

• Familiarity clinical study protocols, statistical analysis plans (SAPs), tables, listings, and figures (TLFs), and statistical programming documentation.

• Experience in generating TLFs, programming macros, and data manipulation using SAS or other statistical programming languages. Experience working on cross-study, integrated data analyses.

• Strong attention to detail and problem-solving skills, with the ability to identify and troubleshoot programming issues.

• Proficiency in using statistical software and programming tools, such as SAS, R, and SQL.

• Effective communication skills, both written and verbal, with the ability to interact professionally with statisticians, study teams, and external partners.

• Ability to work collaboratively in a team environment and adapt to changing priorities and deadlines.

• Experience in statistical programming or clinical research, either through internships, academic research projects, or previous employment, is a plus.

Additional Information

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. 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 protected veteran, or any other legally protected group status.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html