Manager, Biostatistics

Medical Health Sciences Parsippany, NJ San Diego, CA Tampa, FL


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.

The Manager, Biostatistics is responsible for managing and directing statistical programmers on a project, writing statistical sections for protocols, authoring statistical analysis plans, review and quality control of deliverables from the Biometrics department.  He/She will oversee contract research organization (CRO) statistical work and is responsible for overseeing Pacira quality control of statistical deliverables from the CRO.

The Manger, Biostatistics is responsible for ensuring consistency of deliverables across studies in a program (a group of studies to support regulatory submission).

Responsibilities:

  • Writing statistical sections for protocols
  • Perform sample size calculations
  • Writing or reviewing statistical analysis plans for protocols
  • Researching statistical methodologies
  • Provide protocol training at investigator meetings
  • Provide statistical consulting for other departments in the company
  • Program statistical analyses
  • Represent the biostatistics department at internal and external meetings
  • Review and analyze data
  • Managing biostatistics departmental timelines and resources for clinical studies
  • Manage biostatistics CRO
  • Attend meetings with regulatory agencies

Interaction: 

  • The Manager - Biostatistics will interact with team members from medical, clinical operations, project management, CROs and regulatory agencies.

Qualifications:

  • Master’s Degree in statistics, biostatistics or related area from accredited college or university
  • Minimum 2 years of experience in biostatistics or related area

Candidates should have experience in analyzing data from:

  • Efficacy, Parallel. Cross-over, Pharmacokinetic and Dose-response studies.

Knowledge, Skills, and Abilities:

  • Excellent verbal and written English communication skills
  • Demonstrated knowledge of pharmaceutical industry.
  • Demonstrated understanding of drug/device development.
  • Demonstrated knowledge of regulatory process and guidelines.
  • Programming experience in SAS is required; experience in R is a plus.
  • Proven understanding of standard operating procedures, process and quality control associated with biostatistics in the pharmaceutical industry.

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.

At Pacira we are committed to intentionally cultivating a culture of inclusion where all feel welcomed and valued for their background, perspectives, and experiences. We hold one another accountable to promote trust and transparency in support of our communities and collective purpose.