AbbVie
Senior Manager, Statistical Programming
AbbVie - Irvine, California, United States, 92713
Work at AbbVie
Overview
- View job
Overview
Join to apply for the
Senior Manager, Statistical Programming
role at
AbbVie
2 weeks ago Be among the first 25 applicants
Join to apply for the
Senior Manager, Statistical Programming
role at
AbbVie
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 X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.
Job Description
Purpose The Senior 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, Data Sciences, Medical Writing, Regulatory Publishing and Development Operations.
Responsibilities
Lead statistical programming activities for one or more compounds/indications or a therapeutic area.
Manage a team of statistical programmers and resource planning for assigned projects.
Ensure timely deliverables, adherence to quality processes, and consistency across projects.
Develop and oversee SAS programs for creating ADaM data sets following CDISC standards.
Develop and oversee SAS programs for Tables, Listings, and Figures.
Ensure consistency of ADaM data sets for individual studies and integrated data.
Create documentation for regulatory filings, including reviewer guides and data definition documents.
Lead the development of standard SAS Macros and SOPs.
Manage, mentor, and develop career plans for staff.
Participate in recruitment and selection of new staff.
Qualifications
This position requires on-site presence 3 days/week.
MS in Statistics, Computer Science, or related field with 9+ years of relevant experience OR BS with 11+ years.
Minimum 2 years leading a team of statistical programmers.
Deep understanding of SAS programming, CDISC standards, and drug development processes.
Excellent communication skills, both oral and written.
Ability to represent the Statistical Programming organization effectively in cross-functional teams.
Ability to estimate effort for programming activities accurately.
Key Stakeholders
Directors of Statistics
Data Scientists
Medical Writers
Regulatory Publishers
Clinical Project Managers
Additional Information Details about pay range, benefits, and legal disclaimers are included in the original description. Please refer to the full posting for comprehensive information.
Other Details
Seniority level: Mid-Senior level
Employment type: Full-time
Job function: Design, Art/Creative, and IT
Industries: Pharmaceutical Manufacturing and Biotechnology Research
Referrals increase your chances of interviewing at AbbVie by 2x. Get notified about similar jobs in Irvine, CA.
#J-18808-Ljbffr
Senior Manager, Statistical Programming
role at
AbbVie
2 weeks ago Be among the first 25 applicants
Join to apply for the
Senior Manager, Statistical Programming
role at
AbbVie
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 X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.
Job Description
Purpose The Senior 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, Data Sciences, Medical Writing, Regulatory Publishing and Development Operations.
Responsibilities
Lead statistical programming activities for one or more compounds/indications or a therapeutic area.
Manage a team of statistical programmers and resource planning for assigned projects.
Ensure timely deliverables, adherence to quality processes, and consistency across projects.
Develop and oversee SAS programs for creating ADaM data sets following CDISC standards.
Develop and oversee SAS programs for Tables, Listings, and Figures.
Ensure consistency of ADaM data sets for individual studies and integrated data.
Create documentation for regulatory filings, including reviewer guides and data definition documents.
Lead the development of standard SAS Macros and SOPs.
Manage, mentor, and develop career plans for staff.
Participate in recruitment and selection of new staff.
Qualifications
This position requires on-site presence 3 days/week.
MS in Statistics, Computer Science, or related field with 9+ years of relevant experience OR BS with 11+ years.
Minimum 2 years leading a team of statistical programmers.
Deep understanding of SAS programming, CDISC standards, and drug development processes.
Excellent communication skills, both oral and written.
Ability to represent the Statistical Programming organization effectively in cross-functional teams.
Ability to estimate effort for programming activities accurately.
Key Stakeholders
Directors of Statistics
Data Scientists
Medical Writers
Regulatory Publishers
Clinical Project Managers
Additional Information Details about pay range, benefits, and legal disclaimers are included in the original description. Please refer to the full posting for comprehensive information.
Other Details
Seniority level: Mid-Senior level
Employment type: Full-time
Job function: Design, Art/Creative, and IT
Industries: Pharmaceutical Manufacturing and Biotechnology Research
Referrals increase your chances of interviewing at AbbVie by 2x. Get notified about similar jobs in Irvine, CA.
#J-18808-Ljbffr