Manager - Statistical Programming (Hybrid)

Biopharma Careers

United States

On-site

USD 120,000 - 180,000

Full time

14 days+
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Job summary

AbbVie is seeking a Manager of Statistical Programming to lead a team of programmers in neuroscience-focused drug development. You will oversee SAS-based ADaM data creation, Tables, Listings and Figures, and ensure regulatory-ready documentation.

The role requires strong leadership, deep CDISC expertise, and the ability to guide cross-functional collaboration with Statistics, Data Sciences, Medical Writing, and Regulatory Publishing.

Qualifications

  • Bachelors in Statistics or Mathematics required.
  • 10+ years of relevant experience (or 8+ with a Masters).
  • Experience leading a team or project of statistical programmers.

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.
  • Ensures timely deliverables and adherence to quality processes.
  • Develops SAS programs for ADaM data sets following CDISC standards.
  • Develops SAS programs for Tables, Listings and Figures.
  • Ensures consistency of ADaM data sets for studies and integrated data.
  • Creates documentation for regulatory filings and data definitions.
  • Oversees development of standard SAS Macros and SOPs.
  • Provides mentoring to assigned Statistical Programmers and Analysts.

Skills

SAS Programming
CDISC Standards
ADaM Development
Team Leadership
Communication

Education

Bachelor's in Statistics or Mathematics

Tools

SAS

Job description

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.
Qualifications
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 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 this posting 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 and until 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.

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

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