Senior Manager, Biostatistics

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.

Summary:

The Senior 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 Biostatistics department and mentoring of others in the department. The Senior Biostatistician will oversee contract research organization (CRO) statistical work and is responsible for overseeing Pacira quality control of statistical deliverables from the CRO.

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

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

Education and Experience:

• Master's Degree in statistics, biostatistics or related area from accredited college or university
• Minimum 3 years of experience in biostatistics or related area or PhD in statistics, biostatistics or related area and 2 or more 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.

Physical Demands:

While performing the duties of this job, the employee is regularly required to sit, talk, move between spaces, reach with hands and arms, and stoop. Close vision and the need to focus on computer screen, use of hands, fingers and wrist to type on keyboard and manipulate mouse.

Work Environment:

Typical office setting, staff in cubicles, noise level is moderate with consistent printer, telephone ringing and conversation. Employee is located in cubicle setting.

• 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

The base pay range for this role in California is $120,000 - $165,000 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.

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.
Agency Disclaimer: Pacira Biosciences, Inc. (Hereafter, Pacira) does not accept unsolicited resumes from recruiters or employment agencies in response to the Pacira Careers page or a Pacira social media post. Pacira will not consider or agree to payment of any referral compensation or recruiter fee relating to unsolicited resumes. Pacira explicitly reserves the right to hire said candidate(s) without any financial obligation to the recruiter or agency. Any unsolicited resumes, including those submitted to hiring managers, are deemed to be the property of Pacira.