Manager - Statistical Programming (Hybrid)

AbbVie; Irvine (CA); On-site; USD 140,000 - 210,000; Full time

Job summary

AbbVie in Irvine, CA is seeking a Manager of Statistical Programming to lead a team of statistical programmers in the Neuroscience group, guiding SAS programming for ADaM datasets and Tables, Listings and Figures, and ensuring CDISC standards.

You will collaborate with Statistics, Data Sciences, Medical Writing and Regulatory Publishing, mentor staff, manage resources, and drive timely, high-quality deliverables supporting regulatory submissions.

Qualifications

• Bachelor's degree in Statistics or Mathematics.
• 10+ years of relevant experience (or 8+ with a Masters).
• Experience leading a team of statistical programmers.
• Experience with SAS programming concepts and techniques related to drug development.
• In-depth understanding of CDISC Standards.
• Experience with ADaM development and TLF generation.

Responsibilities

• Leads the statistical programming activities for a compound/indication or therapeutic area in early development.
• Leads a team of statistical programmers and manages the resource planning for assigned staff.
• Ensures timely deliverables, that all quality processes are followed and consistency within the projects.
• Develops and oversees the development of SAS programs for the creation of ADaM data sets following CDISC standards.
• Develops and oversees the development of SAS programs for the creation of Tables, Listings and Figures.
• Ensures consistency of ADaM data sets for individual studies and integrated data.
• Creates documentation for regulatory filings including reviewers guides and data definition documents.
• Leads the development of standard SAS Macros and participates in the development of standard operating procedures.
• Provides oversight and mentoring of assigned Statistical Programmers, Statistical Analysts and Senior Statistical Analysts.

Skills

Communication

Cross-functional collaboration

Effort estimation

Education

Bachelor's in Statistics or Mathematics

Master's degree (preferred)

Tools

SAS

Job description

About AbbVie

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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Company Description

About AbbVie

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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

The Manager of Statistical Programming is a strategic role which guides a team of Statistical Programmers in the research and development of new pharmaceutical products. This role is directly responsible for leading the statistical programming activities for the Neuroscience group. The Manager of Statistical Programming must effectively interface with Statistics, Data Sciences, Medical Writing, Regulatory Publishing and Clinical Operations.

Responsibilities

• Leads the statistical programming activities for a compound/indication or therapeutic area in early development.
• Leads a team of statistical programmers and manages the resource planning for assigned staff.
• Ensures timely deliverables, that all quality processes are followed and consistency within the projects.
• Develops and oversees the development of SAS programs for the creation of ADaM data sets following CDISC standards.
• Develops and oversees the development of SAS programs for the creation of Tables, Listings and Figures.
• Ensures consistency of ADaM data sets for individual studies and integrated data.
• Creates documentation for regulatory filings including reviewers guides and data definition documents.
• Leads the development of standard SAS Macros and participates in the development of standard operating procedures.
• Provides oversight and mentoring of assigned Statistical Programmers, Statistical Analysts and Senior Statistical Analysts.

Minimum Job Qualifications

• Bachelors in Statistics or Mathematics
• 10+ years of relevant experience. (or 8+ with a Masters)
• Previous experience leading a team/project of statistical programmers.
• Experience with SAS programming concepts and techniques related to drug development.
• In-depth understanding of CDISC Standards.
• Experience with ADaM development and TLF generation is required

Preferred Qualifications

• Experience with regulatory filings.

Other Required Skills

• Ability to communicate clearly both oral and written.
• Ability to effectively represent the Statistical Programming Organization in cross functional teams.
• Ability to accurately estimate effort required for project related programming activities.

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 Company's sole and absolute discretion unless and until paid and may be modified at the Company’s 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 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