Manager, Safety Statistical Programming (Remote) - AbbVie
Chicago, IL
About the Job
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
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Job Description The Safety Statistical Programming Manager is a strategic role in the emerging field of safety science
He or she will provide programming expertise for development of pooled safety data sets, as well as technical guidance to teams of Statistical Programmers in the research, development, and safety assessment of pharmaceutical products
This role is directly responsible for leading the statistical programming activities for development and maintenance of integrated clinical safety data for multiple compounds and indications
The Safety Statistical Programming Manager must effectively interface with team members from Statistics, Data Sciences, Pharmacovigilance and Patient Safety, Data Analytics, Medical Writing, Regulatory Publishing and Clinical Operations
Responsibilities: + Leads the statistical programming activities for three or more compounds in creating integrated safety data sets to support safety monitoring, signal detection, clinical safety analytics and regulatory submissions
+ Leads a team of statistical programmers and manages the resource planning for assigned staff
+ Ensures timely deliverables, that all quality processes are followed consistently within the projects
+ Develops and oversees the development of SAS programs, product safety data integration plan, metadata, ADaM specifications, ADaM data sets following CDISC standards and Tables, Listings and Figures (TLFs)
+ Responsible for harmonizing SDTM and non-standard source data across multiple studies, creation and validation of ADaM and TLFs for all safety deliverables following AbbVie’s SOPs, department, and project standards
+ Demonstrated satisfactory ability to interpret statistical analysis plans to develop analysis data set specifications
+ Creates documentation for regulatory filings including reviewers guides and data definition documents
+ Leads the development of data extraction and transformation automation tools, standard SAS Macros and participates in the development of standard operating procedures and cross-functional process improvement initiatives
+ Provides oversight and mentoring of assigned Statistical Programmers, Statistical Analysts and Senior Statistical Analysts
+ Works effectively with diverse group of cross functional team members within Data and Statistical Sciences and Patient Safety teams in resolving programming and data issues
+ Is compliant with training requirements
This role can be based remotely within the US (#LI-Remote)
Qualifications Candidates must have an MS in Computer Science, Statistics or a related field with 8+ years of relevant experience (OR BS in Computer Science, Statistics, or a related field with 10+ years of relevant experience)
Qualified candidates will also have the following: + Previous experience leading a team of statistical programmers
+ Experience in harmonizing clinical study data from multiple studies with diverse study designs, data standards spanning multiple indications (ideally in Oncology, Neuroscience and Specialty therapeutic areas)
+ Experience in leading statistical programming activities supporting IB, DSUR, PSUR, Integrated Summary of Safety (ISS), Annual Safety Reports and/or other safety analysis
+ Experience in leading studies with hands-on experience for developing ADaM specs, SAS Programs and TLFs
+ Experience in SAS Programming on LINUX, LINUX shell scripting, developing data transformation automation tools and experience in programming languages such as R, Python is preferable
+ In-depth understanding of SAS programming concepts and techniques related to drug development and demonstrated competency with hands-on experience in SAS programming, macro and utilities development
+ In-depth understanding of CDISC Standards (SDTM and ADaM)
+ In-depth understanding of the drug development process, including experience with regulatory filings
At AbbVie, we look for strong leadership capabilities and often ask candidates to demonstrate their ability to: + Communicate clearly and effectively, influencing cross-functionally + Build strong relationships with a diverse set of stakeholders + Successfully manage a project (organization, deliverables, expectations) 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
+ 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, 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
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