Lead Biostatistician, Late-Phase Trials

Pacira BioSciences, Inc.; Littleton (NJ); On-site; USD 141,000 - 194,000; Full time

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

Flexible Spending Account

Health Savings Account

Employee Assistance Program

401(k) with company match

Paid holidays

Job summary

Pacira BioSciences, Inc. seeks a lead statistician to provide leadership on late-phase clinical studies, owning all statistical aspects and serving as a key department representative within the company.

You will work on observational and investigational designs and may lead the statistics group in a technical area. The role requires mentoring staff, collaborating with clinical, data management, and publication teams, and ensuring timely, high-quality deliverables that meet SOPs.

Qualifications

• Ph.D. or master's degree in Biostatistics or closely related discipline.
• Minimum 5 years of hands on Biostatistics experience in the Pharmaceutical or Biotech industry.
• Minimum 3 years managing and implementing working relationships with external agencies, such as CROs, consultant groups, and research committees.
• Minimum of 3 years of SAS and/or R programming experience.
• Experience in medical device and gene therapy not required but highly preferred.
• 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.
• Demonstrated understanding of observational study designs, multivariable modeling longitudinal data analysis and causal inference techniques.
• Proven ability to represent Biostatistics and Programming in multidisciplinary meetings.
• Proven ability to work in a fully self-directed manner.
• Proven ability to independently write SAS and/or R programs in adherence to objectives.
• Knowledge of clinical terms and late phase/post-marketing research context.
• Ability to travel (overnights required) approximately 20%.

Responsibilities

• Oversee statistical support to multiple project teams; define late-phase strategy and assess methodologies.
• Conduct statistical analyses, prepare methods and results sections for CSR; provide statistical conclusions.
• Provide guidance on derived variables for TLGs; ensure data collection consistency across projects.
• Plan and track project activities, timelines, and resources; optimize capacity.
• Mentor staff; promote teamwork, quality, and SOP compliance within the department.
• Maintain awareness of industry standards and update procedures to stay compliant.
• Represent the department in cross-functional meetings and advocate statistical thinking.

Skills

Leadership

Project management

Interpersonal skills

English communication

Statistical thinking

Observational study designs

Multivariable modeling

Causal inference techniques

Self-directed

Presentation skills

Education

Ph.D. or master's degree in Biostatistics

Tools

SAS

R

Job description

Pacira BioSciences, Inc. seeks a lead statistician to provide leadership on late-phase clinical studies, owning all statistical aspects and serving as a key department representative within the company.

You will work on observational and investigational designs and may lead the statistics group in a technical area. The role requires mentoring staff, collaborating with clinical, data management, and publication teams, and ensuring timely, high-quality deliverables that meet SOPs.