Senior Manager, Statistical Programming - Oncology Early Development

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

Benefits offered by this job

Paid time off

Medical/Dental/Vision insurance

401(k) participation

Job summary

PowerToFly is looking for a Senior Manager, Statistical Programming to oversee statistical programming for Oncology Early Development clinical projects. This role involves leading a team and ensuring the integrity of analyses for first-in-human clinical trials.

The ideal candidate will have significant SAS programming experience, lead statistical programming efforts, and handle regulatory documentation. A comprehensive benefits package is offered.

Qualifications

• 9+ years of relevant experience with an MS or 11+ years with a BS.
• Minimum of 2 years experience leading a team of statistical programmers.
• In‑depth understanding of SAS programming concepts and techniques.

Responsibilities

• Leads statistical programming activities for projects.
• Develops SAS programs for ADaM datasets and TLFs.
• Creates documentation for regulatory filings.

Skills

SAS programming concepts

Drug development

Regulatory filings

Team leadership

Communication skills

Education

MS in Statistics, Computer Science, or related field

BS in Statistics, Computer Science, or related field

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 the 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. The individual may also need to manage other regular or contract statistical programmers.

Responsibilities

• Leads the statistical programming activities for one or more compounds/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 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

• 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 employer 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.