Manager, Statistical Programming

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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.

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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:

The Manager, Statistical Programming will work in Statistical Programming group to manage and support Statistical Programming deliverables for clinical studies.

Essential Duties & Responsibilities:

• Technical lead and project manager for multiple studies managing all aspects of study deliverables related to statistical and clinical programming as needed
• Represent the statistical programming team at Study Management Team and Clinical Development meetings to address deliverables and timelines
• Address resourcing to adequately staff projects as needed
• Assist in the review of key study-related documents produced by other functions, e.g. SAP, case report form, data management plan, database specifications, EDC data structures, DMC plans and other clinical documents
• Write, test, and validate SAS programs to produce analysis datasets, TLGs and presentation output, to be included in reports for submission to regulatory agencies, publications and other communications as needed
• Understand and execute department-, product- and study-level macros and utilities. Write, test, and validate product- and study-level macros and utilities
• Be a technical resource for programming group to provide advice on complex programming tasks and/or standards.
• Contribute to the development review of Statistical Programming policies, standard operating procedures, and other controlled documents
• Interface with outsourcing partners and vendor

Supervisory Responsibilities:

No supervisory responsibilities

Interaction:

Interact and communicate with R&D Statisticians, Data Managers, Clinical Operations, Medical Monitors, Medical Writing and Medical Directors to address programming related study deliverables.

Education and Experience:

• Bachelor's degree or above in Computer Science, Statistics, Mathematics, Life Sciences or other relevant scientific subject, or equivalent related experience required.
• Minimum 2+ years' clinical research and development programming experience using SAS or advanced degree required.

Qualifications:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Knowledge, Skills, and Abilities:

• Knowledge of SDTM and ADaM standards, able to write CDISC standard dataset specifications and follow specifications to create SDTM and ADaM datasets (as needed)
• Computer programming using SAS essential, and experience with R and Python desirable
• Fundamentals of project planning and management
• Drug development process
• Excellent verbal and written communication skills
• Ability to effectively collaborate in a dynamic environment
• Expert level SAS programmer with experience in delivering on complex programming assignments and analysis
• Expert level knowledge and extensive hands-on experience of CDISC methodologies
• Experience leading or working with centralized teams for Statistical Programming
• Experience in FDA/EMEA/CFDA trial and regulatory submissions
• Experience with the drug development process (pre-, early, late and/or observational) in related industries or academic research

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:

The work will be in a typical office environment (cubicles, offices, conference rooms, etc.) with heavy computer use.

• 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 is $103,000 to 140,000 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: 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.