The Sr. Manager, Statistical Programming serves as a functional lead, working closely with Biostatistics and Data Management and responsible for clinical trial data programming activities to produce high quality and timely deliverables for biometrics and other internal stakeholders. This position will report into a Director of Statistical Programming and will interact regularly with key stakeholders within Biometrics. The ideal candidate will be a highly experienced Statistical Programming Lead  with 15+ years of solid industry experience working in a regulated global environment while also demonstrating know-how, flexibility to shift between projects, ability to seek solutions proactively, and work independently. 

Responsibilities:

• Demonstrated experience with CDASH and CDISC data standards (SDTM, ADaM)
• In-depth knowledge of data standards and demonstrated experience in the handling data in diverse types. Import data from various sources.
• Program quality control checks for source data and reporting data issues.
• Write programming code following established Good Programming Practices
• Develop SAS Macros as needed.
• Develop high quality graphs in addition to developing Tables, listings and figures.
• Program/QC SDTM and ADaM datasets and TLFs from external vendors.
• Program to create statistical analysis tables, listing and figures.
• Provides programming support for development or verification of data and analysis, adhoc analysis and. Perform quality check programming activities for CRO deliverables.
• QC  CRO deliverables.
• Review and comment on CRF, annotated CRF, edit checks, Statistical Analysis Plan and other clinical study related documents.
• Review table specifications, analysis data sets, and mapping files for analysis data sets
• Produce or QC SDTM/ADaM datasets and associated define.xml, and tables, figures, and listings (TFLs) for individual studies .
• Create and/or QC TFLs to support publications, internally decision making, board meeting materials, exploratory analysis, or ad-hoc requests with tight timelines
• Ensures stat programming related documentations in an audit-ready state and review for Trial Master Files
• Ensures compliance with FDA regulations, GCP, ICH guidelines

Qualifications:

• Bachelor’s degree or higher in a technical, scientific, or analytic discipline
• Minimum 6+ years of biotechnology or pharmaceutical experience.
• Excellent working knowledge of Base SAS, SAS/STAT, SAS Macro language, SQL and SAS/GRAPH
• Experience using SAS version 8 or higher.
• Ability to execute and manage multiple simultaneous projects and deadlines with shifting priorities and resources in a fast-paced working environment.
• In-depth knowledge in the analysis of clinical trial data, including integrated analysis of clinical trial data with other data types (biomarker, PK/PD, etc.)
• Solid understanding of industry standards such as CDISC, specifically SDTM, ADaM and controlled terminology and/or ADaM and Pinnacle 21 validation
• Demonstrated ability to rapidly adapt to changing project and strategic requirements. Takes a fit-for-purpose mindset to daily work as well as long-term vision.
• Produce timely, high quality, and reliable clinical trial data listings, tables, and figures.
• Solid knowledge of pharmaceutical and regulatory requirements, procedures, and policies, including GCP, ICH, 21 CFR part 11, and other related guidance documents
• Strong verbal and written communication skills
• Ability to work well in a cross-functional teams as a contributor.
• Excellent interpersonal skills and demonstrated ability to establish and maintain professional and productive cross-functional working relationships.

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