Manager, Safety Statistical Programming

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

The Manager of Safety Statistical Programming is a strategic role in the emerging field of safety science providing programming expertise for development of pooled safety data sets and providing technical guidance to team 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 Manager of Safety Statistical Programming 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.

• Be compliant with training requirements.

Qualifications

• 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.

• Previous experience leading a team of statistical programmers.

• 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).

• 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 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 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 the drug development process, including experience with regulatory filings.

• Strong technical and communication skills, 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

Applicable only to applicants