Senior Manager

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.

Requirements

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:

1. programming languages such as Base SAS, SAS/STAT, & SAS Macro;
2. programming in pharmaceutical clinical trials, including drafting of technical programming specifications; &
3. 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.

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