Senior Statistical Analyst - Programming - Oncology (Hybrid)

AbbVie; Irvine (CA); On-site; USD 110,000 - 170,000; Full time

Job summary

AbbVie in Irvine, CA is seeking a Senior Statistical Analyst to lead the statistical programming for clinical studies. You will develop SAS programs, create ADaM datasets, and generate Tables, Listings and Figures while ensuring CDISC standards are met.

You will mentor junior programmers, collaborate with Statistics, Data Sciences, Medical Writing and Regulatory Publishing, and support regulatory filings with clear documentation.

Qualifications

• Bachelor's degree in Statistics, Computer Science or a related field.
• 8+ years of relevant experience in quantitative analysis (or 6+ with a Masters).
• Experience with SAS Programming.
• Experience leading programming for clinical trials.

Responsibilities

• Leads the statistical programming activities for projects with lower complexity.
• Leads the statistical programming activities for studies.
• Develop SAS programs for the creation of ADaM data sets following CDISC standards.
• Develop SAS programs for the creation of Tables, Listings and Figures.
• Validation of ADaM data sets, Tables, Listings and Figures.
• Create specifications for the structure of ADaM data sets for individual studies and integrated data.
• Create 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 and Statistical Analysts.

Skills

SAS Programming

Leadership

Statistical Analysis

Communication

Education

Bachelor's degree in Statistics, Computer Science or related field

Master's degree in Statistics or related field

Tools

R Programming

Job 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.

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 Senior Statistical Analyst is a key role in the research and development of new pharmaceutical products. The primary responsibilities for this role include the analysis and reporting of clinical trial data and leading the statistical programming activities for clinical studies and projects with lower complexity. The Senior Statistical Analyst interfaces with Statistics, Data Sciences, Medical Writing, Regulatory Publishing and Clinical Operations.

Responsibilities:

• Leads the statistical programming activities for projects with lower complexity.
• Leads the statistical programming activities for studies.
• Develop SAS programs for the creation of ADaM data sets following CDISC standards.
• Develop SAS programs for the creation of Tables, Listings and Figures.
• Validation of ADaM data sets, Tables, Listings and Figures.
• Create specifications for the structure of ADaM data sets for individual studies and integrated data.
• Create 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 and Statistical Analysts.

Qualifications

Minimum Qualifications

• Bachelors in Statistics, Computer Science or a related field
• 8+ years of relevant experience in quantitative analysis (or 6+ with a Masters)
• Experience with SAS Programming
• Experience leading programming for clinical trials

Preferred Qualifications

• Masters Degree in Statistics, Computer Science or related field
• R Programming experience
• Oncology specific experience

Other Required Skills

• Indepth understanding of SAS programming concepts and techniques related to drug development.
• Fundamental understanding of CDISC Standards.
• Fundamental understanding of the drug development process, including experience with regulatory filings.
• Ability to communicate clearly both oral and written.
• Ability to accurately estimate effort required for study related programming activities.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

• 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 short-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.

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