Senior Manager, Statistical Programming - Oncology Early Development

AbbVie; North Chicago (IL); On-site; USD 120,000 - 150,000; Full time

Benefits offered by this job

Paid time off (vacation, holidays, sick)

Medical/dental/vision insurance

401(k) plan

Job summary

AbbVie is seeking a Senior Manager of Statistical Programming in North Chicago, Illinois. The role is focused on Oncology Early Development, overseeing statistical programming and analysis tasks carried out by CROs.

You will lead and manage statistical programmers, ensuring data integrity and high quality for clinical trials while developing SAS programs. Candidates should possess strong knowledge of SAS programming and drug development processes, with relevant experience in team management.

Qualifications

• 9+ years of relevant experience with MS or 11+ years with BS.
• 2+ years of team leadership experience.
• In-depth SAS programming and CDISC standards knowledge.

Responsibilities

• Lead statistical programming activities for multiple compounds.
• Manage statistical programming teams and resources.
• Ensure timely deliverables and quality processes.

Skills

SAS programming

Statistical analysis

Cross-functional communication

Team leadership

CDISC Standards

Education

MS in Statistics or related

BS in Statistics or related

Job description

Job Description

The Senior Manager, Statistical Programming performs statistical programming and analysis oversight for Oncology Early Development (OED) clinical projects conducted by CROs. This individual is responsible for overseeing several compounds/indications on all statistical programming related tasks delivered by CROs. The goal is to ensure data integrity and high quality of all analysis for oncology first-in-human clinical trials up through clinical proof of concept. This individual also performs hands‑on programming to validate analysis datasets and TLFs delivered by CROs, and supports in‑house studies for the full set of analysis tasks. This individual may need to manage other regular or contract statistical programmers.

Responsibilities

• Leads the statistical programming activities for one or more compounds or indications or a therapeutic area.
• Manages a team of statistical programmers and the resource planning for their assigned projects.
• 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 the development of standard operating procedures.
• Manages, mentors and creates career development plans for assigned staff.
• Participates in the recruitment and selection of new staff.

Qualifications

• MS in Statistics, Computer Science or a related field with 9+ years of relevant experience, OR BS in Statistics, Computer Science or a related field with 11+ years of relevant experience.
• Minimum of 2 years 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 orally and in writing.
• Ability to effectively represent the Statistical Programming Organization in cross‑functional teams.
• Ability to accurately estimate effort required for project‑related programming activities.

Benefits

• 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.