Manager, Statistical Programming

Pacira Pharmaceuticals, Inc.•Parsippany-Troy Hills, NJ

13h

About The Position

At Pacira, innovation meets purpose. Pacira BioSciences, Inc. is a pioneer in non-opioid pain management and regenerative health solutions. Today, we’re building on that legacy with next-generation innovations for chronic, postsurgical, and musculoskeletal pain. Our culture is built on collaboration, innovation, and a shared commitment to helping patients recover faster. We are redefining what’s possible in pain management—and we can’t do it without talented people like you. Why Join Us? At Pacira, every career is more than a job. Our mission drives us, and every day, we challenge ourselves to achieve the extraordinary. Integrity is at the core of who we are. We value diverse perspectives and the collective strength of a unified team. Join the team in making better possible for patients everywhere. Summary: The Manager, Statistical Programming will work in Statistical Programming group to manage and support Statistical Programming deliverables for clinical studies.

Requirements

Bachelor’s degree or above in Computer Science, Statistics, Mathematics, Life Sciences or other relevant scientific subject, or equivalent related experience required.
Minimum 2+ years' clinical research and development programming experience using SAS or advanced degree required.
Knowledge of SDTM and ADaM standards, able to write CDISC standard dataset specifications and follow specifications to create SDTM and ADaM datasets (as needed)
Computer programming using SAS essential, and experience with R and Python desirable
Fundamentals of project planning and management
Drug development process
Excellent verbal and written communication skills
Ability to effectively collaborate in a dynamic environment
Expert level SAS programmer with experience in delivering on complex programming assignments and analysis
Expert level knowledge and extensive hands-on experience of CDISC methodologies
Experience leading or working with centralized teams for Statistical Programming
Experience in FDA/EMEA/CFDA trial and regulatory submissions
Experience with the drug development process (pre-, early, late and/or observational) in related industries or academic research

Responsibilities

Technical lead and project manager for multiple studies managing all aspects of study deliverables related to statistical and clinical programming as needed
Represent the statistical programming team at Study Management Team and Clinical Development meetings to address deliverables and timelines
Address resourcing to adequately staff projects as needed
Assist in the review of key study-related documents produced by other functions, e.g. SAP, case report form, data management plan, database specifications, EDC data structures, DMC plans and other clinical documents
Write, test, and validate SAS programs to produce analysis datasets, TLGs and presentation output, to be included in reports for submission to regulatory agencies, publications and other communications as needed
Understand and execute department-, product- and study-level macros and utilities. Write, test, and validate product- and study-level macros and utilities
Be a technical resource for programming group to provide advice on complex programming tasks and/or standards.
Contribute to the development review of Statistical Programming policies, standard operating procedures, and other controlled documents
Interface with outsourcing partners and vendor