Associate Director, Biostatistics at Pacira Pharmaceuticals Inc in parsippany, New Jersey

Job Description:

Description

About Pacira

Pacira BioSciences, Inc. is a leading provider of non-opioid pain management and regenerative health solutions dedicated to improving outcomes for health care practitioners and their patients. Our in-depth knowledge of non-opioid pain management, coupled with our passion for advancing patient care, drives our commitment to providing solutions that address unmet medical needs and improve clinical results.

Why work with us?

Rarely do you have an opportunity to do work that really matters. What drives us is our mission. What makes us successful are our people. At Pacira, you are part of an inclusive culture that fosters collaboration, growth, and innovative thinking - a place where you can make an impact and help change the standard of care in non-opioid pain management. Be part of our movement, let's pursue excellence together.

Responsibilities:

• Oversee statistical support to multiple project teams. Collaborate with clinical and regulatory leads in defining general strategic approach, creating clinical development plans (CDP), and producing individual protocols. Work independently, or with other statistical departmental members or consultants, to develop effective statistical approaches applicable to project.


• Oversee execution of statistical analyses, preparation of the statistical methods and results sections for clinical study reports (CSR), and production of overall summaries. Review and approve key results memos and statistical conclusions. Provide guidance to the clinical and regulatory teams regarding conclusions and inferences from the data package. Ensure statistical representation at regulatory or other external meetings. Completed data package relevant for submission or making key decisions. Statistical deliverables consistently compliant, in timing and quality, with SOPs and departmental standards.


• Provide general guidance on definition and documentation of key derived variables needed to support production of tables, listings, and graphs (TLG). Effect consistency of data collection and analysis across project or area. Analysis datasets that are quality controlled, sufficient to produce TLG for reports, and consistent within projects. General compliance with Sanofi-Aventis standard data models, e.g. CIDSC.


• Plan and track project activities, timelines, and resource use across projects. Provide justification for planned resource needs. Seek to optimize resource utilization and capacity. Accurate plans, well-managed projects, capacity to apply extra resources in urgent situation.


• Ensure mentoring and development of staff. Encourage personal development in the context of project work. Learn and apply techniques to promote teamwork, quality, and motivation. Manage conflict. Productive work environment, individual growth, development of strong contributors. Staff compliance with SOPs and departmental policies.


• Maintain awareness of industry standards, regulatory requirements, and departmental guidelines and SOP. Within area of control, update procedures or practices as needed to remain in compliance. Procedures and practices meet industry standards and are consistent with internal SOP.


• Serve as departmental representative on division or corporate-wide teams. Advocate application of statistical thinking in decision-making. Work effectively with leaders in other functional areas. Effective corporate use of statistical thinking. Efficient processes in clinical development and operations.

Qualifications:

• PH.D. or Master's degree in Bio-Statistics or closely related discipline from accredited college or university.


• Minimum 5 years of hands on Bio-statistics experience in the Pharmaceutical or Biotech industry; , including significant interactions with regulatory bodies and experience in neuroscience area


• Minimum 3 years' experience in Neuroscience or Pain clinical trials


• Minimum 3 years' experience managing and implementing working relationships with external agencies, such as CRO, consultant groups, and research committees


• Minimum of 3 years of SAS programming experience.


• Demonstrated leadership, project management, and interpersonal skills


• Excellent written and verbal English communication skills


• Excellent presentation skills to groups of varied size and make up.


• Demonstrated broad knowledge and superior understanding of advanced statistical concepts and techniques


• Proven ability to innovatively apply technical principles, theories, and concepts to pharmaceutical clinical development and life cycle management


• Proven success, through previous submissions or interactions, in meeting regulatory guidelines and requirements for drug development


• Demonstrated in-depth understanding of the regulatory drug submission / approval process regionally and globally


• Proven ability to effectively represent Biostatistics and Programming in multidisciplinary or cross-functional meetings


• Proven ability to work in a fully self-directed manner


• Proven ability to independently write SAS programs in adherence to clinical and statistical objectives


• Demonstrated knowledge of clinical terms, clinical study designs and the drug and/or device approval process.


• Demonstrated knowledge of the drug/device approval process is required.


• Ability to travel (overnights required) approximately 20%

EEO Statement

Pacira is proud to be an Equal Opportunity Employer and does not discriminate against applicants because of race, color, religion, sex (including gender identity, sexual orientation, and pregnancy), national origin, age (40 or older), veteran status, disability or genetic information, or any other characteristic protected under applicable federal, state, or local law.

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