Job Information
AbbVie Senior Manager, Statistical Programming in Irvine, California
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 Twitter, Facebook, Instagram, YouTube and LinkedIn.
Job Description
Key Responsibilities
Responsible for leading the statistical programming activities for one or more compounds/indications or a therapeutic area.
Manage a team of statistical programmers in the research and development of new pharmaceutical products.
Interface with Statistics, Data Sciences, Medical Writing, Regulatory Publishing and Development Operations.
Employ experience in programming languages such as Base SAS, SAS/STAT and SAS Macro.
Ensure timely deliverables, that all quality processes are followed, and consistency within the projects.
Program in pharmaceutical clinical trials, including drafting of technical programming specifications.
Develop and oversee the development of SAS programs for the creation of ADaM data sets following CDISC standards.
Program and validate ADaM datasets tables, listings and figures for regulatory submission deliverables, publications and presentations.
Ensure consistency of ADaM data sets for individual studies and integrated data.
Create documentation for regulatory filings including reviewers guides and data definition documents.
Lead the development of standard SAS Macros and the development of standard operating procedures.
Manage, mentor and create career development plans for assigned staff.
Participate in the recruitment and selection of new staff.
Qualifications
Must possess a Bachelor’s degree or foreign academic equivalent in Statistics, Biotechnology or a highly related field of study with 5 years of related experience.
Alternatively, employer will accept a Master’s degree or foreign academic equivalent in the aforementioned fields.
Each alternative with at least 2 years of experience in the following:
programming languages such as Base SAS, SAS/STAT, & SAS Macro;
programming in pharmaceutical clinical trials, including drafting of technical programming specifications; &
programming and validating ADaM datasets tables, listings & figures for regulatory submission deliverables, publications & presentations.
Salary Range: $138,029.93 - $157,500.00 per year
Apply online at https://careers.abbvie.com/en. Refer to Req ID: REF27633R.
Additional Information
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 and long-term incentive programs.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status. US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
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