Associate Director, Late Phase Research Biostatistics

Pacira BioSciences, Inc.; Parsippany-Troy Hills (NJ); Sur place; USD 141 000 - 194 000; Plein temps

Avantages offerts par ce poste

Medical, Prescription, Dental, Vision

Flexible Spending Account

Employee Assistance Program

Mental Health Resources

Disability Coverage

Life insurance

Critical Illness and Accident Coverage

Legal and Identity Theft Protection

Pet Insurance

Fertility and Maternity Assistance

401(k) with company match

Flexible Time Off

Paid Holidays

Paid Parental Leave

Résumé du poste

Pacira BioSciences, Inc. seeks a lead statistician to guide late-phase clinical studies across multiple projects. You will oversee statistical analysis, design observational and investigational studies, and ensure robust scientific validity. You may serve as department leader in your area and mentor staff.

The role requires 5+ years in biostatistics, strong SAS/R programming, and proven collaboration with CROs and research teams. Travel ~20% and a commitment to quality SOPs are expected.

Qualifications

• Ph.D. or master's degree in Biostatistics or closely related discipline from accredited college or university.
• Minimum 5 years of hands on Biostatistics experience in the Pharmaceutical or Biotech industry.
• 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 and/or R programming experience.
• Experience in medical device and gene therapy is preferred but not required.

Responsabilités

• Oversee statistical support to multiple project teams and define general strategy.
• Conduct statistical analyses and prepare methods and results for CSR; produce summaries.
• Provide guidance on derived variables to support TLG production and data consistency.
• Plan and track project activities, timelines, and resource use across projects.
• Ensure mentoring and development of staff; promote teamwork and SOP compliance.
• Maintain awareness of regulatory standards and SOPs; stay compliant.
• Represent Biostatistics in cross-functional and division-wide teams.

Connaissances

Biostatistics

Leadership

Project management

English communication

Statistical thinking

Formation

Ph.D. or master's in Biostatistics or closely related

Outils

SAS

R

Description du poste

Overview

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

Provide leadership and guidance as the lead statistician on a project team. For one or more projects, be accountable for all statistical aspects of late phase clinical studies, including observational and investigational study designs and scientific validity. Act as key statistical function representative within company. In some cases, incumbent could serve as department leader in specific technical area.

Responsibilities

Essential Duties & Responsibilities

• Oversee statistical support to multiple project teams. Collaborate with cross-functional and clinical leads in defining general strategic approach, creating late phase research strategy, and producing individual protocols. Work independently, or with other statistical departmental members or consultants, to develop effective statistical approaches applicable to project.
• Conduct statistical analyses, prepare 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 cross-functional teams regarding conclusions and inferences from the data package. Ensure statistical representation at rcross-functional or external meetings. Completed data package relevant for publication 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.
• 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. .

Supervisory Responsibilities

This position will have supervisory responsibility and may manage 1-3 direct reports.

Interaction

The incumbent will work closely with clinical research and operation, data management, , publication.

Qualifications

Education and Experience

• Ph.D. or master's degree in Biostatistics or closely related discipline from accredited college or university.
• Minimum 5 years of hands on Biostatistics experience in the Pharmaceutical or Biotech industry;
• 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 and(or) R programming experience.
• Experiences 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 in-depth understanding of observational study designs, including multivariable modeling longitudinal data analysis and causal inference techniques.
• 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 and(or) R programs in adherence to clinical and statistical objectives
• Demonstrated knowledge of clinical terms, clinical study designs and late phase/post-marketing research context.
• Ability to travel (overnights required) approximately 20%

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Ability to safely navigate in a traditional office environment as well as in Health Care facilities. Will travel approximately 20%.

Work Environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

The work setting is consistent of a typical pharmaceutical office environment with offices and cubicles.

Benefits

• Medical, Prescription, Dental, Vision Coverage
• Flexible Spending Account & Health Savings Account with Company match
• Employee Assistance Program
• Mental Health Resources
• Disability Coverage
• Life insurance
• Critical Illness and Accident Insurance
• Legal and Identity Theft Protection
• Pet Insurance
• Fertility and Maternity Assistance
• 401(k) with company match
• Flexible Time Off (FTO) and 11 paid holidays
• Paid Parental Leave

Pay Transparency

The base pay range for this role is $141,000 to $194,000 per year. The range is what we reasonably expect to pay for this role. The range considers a wide range of factors that are considered in making compensation decisions, including but not limited to: geographic markets, business or organizational needs, skill sets, experience, training, licensure, and certifications. Depending on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered.

EEO Statement

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.