Manager, Statistical Programming

ABBVIE; Irvine (CA); On-site; USD 110,000 - 209,000; Full time

Job summary

AbbVie is seeking a Manager of Statistical Programming in Irvine, CA to lead a team of statisti cal programmers in early development efforts. You will oversee SAS programming for ADaM data sets, Tables, Listings and Figures, align with CDISC standards, and partner withStatistics, Data Sciences, Medical Writing and Regulatory teams.

You will mentor staff, manage resource planning, and ensure timely, compliant deliverables.

Qualifications

• MS in Statistics, Computer Science or related field with 8+ years of relevant experience or BS+10+ years
• Experience leading a team of statistical programmers
• Deep SAS programming knowledge for drug development and CDISC standards

Responsibilities

• Leads the statistical programming activities for a compound/indication or therapeutic area in early development.
• Leads a team of statistical programmers and manages resource planning for assigned staff.
• Ensures timely deliverables and adherence to quality processes across projects.
• Develops and oversees SAS programs for ADaM data sets and Tables, Listings and Figures.
• Ensures consistency of ADaM data sets across studies and integrated data.
• Creates regulatory documentation including reviewers guides and data definition documents.
• Leads development of standard SAS Macros and SOPs.
• Provides oversight and mentoring of assigned programmers and analysts.

Skills

Leadership

Communication

Cross-functional collaboration

Project management

Analytical thinking

Education

MS in Statistics or related field

BS in Statistics or related field

Tools

SAS programming

CDISC Standards

ADaM data sets

SAS Macros

Job description

• Compensation: USD 109,500 - USD 208,500 - yearly

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 a compound/indication or therapeutic area in early development. 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.

Qualifications

• MS in Statistics, Computer Science or a related field with 8+ years of relevant experience. OR BS in Statistics, Computer Science or a related field with 10+ years of relevant experience.
• Previous experience leading a team of statistical programmers.
• In-depth understanding of SAS programming concepts and techniques related to drug development.
• In-depth understanding of CDISC Standards.
• In-depth understanding of the drug development process, including experience with regulatory filings.
• 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 orlocal law:

The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeof thisposting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location,andwemayultimatelypaymore or less than the posted range. This range may bemodifiedin thefuture.

We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.

This job is eligible toparticipatein our long-term incentiveprograms.

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus,commission,incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employeeremainsin the Company's sole andabsolutediscretion unless anduntil paid andmay bemodifiedat the Company’s sole and absolute discretion, consistent withapplicable 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.

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