Senior Manager, Biostatistics

Pacira BioSciences, Inc.; Parsippany-Troy Hills (NJ); On-site; USD 120,000 - 165,000; Full time

Benefits offered by this job

Health Coverage

FSA & HSA

Employee Assistance

Mental Health Resources

Disability Coverage

Life Insurance

Critical Illness Insurance

Identity Protection

Pet Insurance

Fertility Support

401(k) Match

Flexible Time Off

Paid Holidays

Parental Leave

Job summary

Pacira BioSciences, Inc. is seeking a Senior Manager, Biostats to lead design and execution of clinical studies. You will manage CROs, author and review SAPs, TOCs, and SOPs, and validate results with hands-on programming in SAS or R.

You will guide biometrics activities, present findings to Pacira stakeholders, and contribute to study-level or program-level meetings. Qualified applicants have advanced degree and extensive biostatistics experience in pharma.

Qualifications

• Master's degree in Statistics or related field; PhD with clinical trial exp preferred.
• Minimum 5 years programming in SAS/SQL with pharma industry experience.
• Minimum 3 years' project management experience.

Responsibilities

• Design and implement statistical analyses for studies and publications.
• Develop SAS programs and validate outputs.
• Manage vendor and CRO programming activities.
• Lead biometrics meetings and communicate progress to stakeholders.

Skills

SAS

R

SQL

Biostatistics

Project Management

English Communication

Education

Master's in Statistics

PhD in Statistics

Tools

SAS

R

Job description

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

The Senior Manager, Biostats will provide leadership in designing and implementation of clinical studies. Provide scope and engage CROs to ensure high-quality execution. Responsibilities also include authoring protocol, design elements, authoring SAPs or reviewing SAPs, TOCs and adherence to SOPs. Hands-on contributions including validation and independent verification of results are included in responsibilities, The senior manager may also lead study level or program level Biometrics meetings to ensure the plans are clearly communicated with CROs and Pacira stakeholders and progress is communicated on regular basis. Senior Manager may also participate in hiring talent as needed based on Biometrics lead guidance and expectations. Expert level knowledge is required for SAS or R.

Responsibilities

Essential Duties & Responsibilities

• Develop statistical analysis plans for data and statistical outputs to support studies, abstracts, posters and publications including resource needs and timelines.
• Independently create SAS programs or validate data / statistical outputs.
• Independently perform quality control on analytical outputs created internally or by vendors.
• Provide guidance to programmers (Pacira and vendors) to ensure accuracy and use of best practices.
• Provide support in managing statistical programming performed by vendors.
• Provide reports to Associate Director or Head of Biometrics on status of statistical deliverables and outputs.
• Escalate issues in a timely manner to ensure study or program integrity.

Qualifications

Supervisory Responsibilities

• Supervision and mentoring of statistical analyst or Manager, Biostatistics as applicable.
• Oversight of vendors including CROs.
• Project management within statistics.

Interaction

This role interacts with clinical, regulatory functions including clinical study teams, data and statistical programmers, biostatisticians, project management, IT and external vendors.

Education and Experience

• Master's degree from an accredited college or university in Statistics, Mathematics, Information Technology, Computer Science, or a related field; or Ph.D. in Statistics or a related field with a minimum of 2 years of clinical trial experience.
• Minimum 5 years of experience programming in SAS / SQL with at least 5 years in the pharmaceutical industry. Relevant experience obtained during a Ph.D. program may be considered.
• Minimum 3 years' experience managing projects. Relevant experience obtained during a Ph.D. program may be considered.

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:

• Demonstrated resource management skills
• Problem solver and with strategic analytical thinking
• Proven project management skills
• Proven advanced programming ability in SAS or R including advanced level of knowledge of statistical methods including adaptive designs and guidances e.g. ICH E9
• Knowledge of Therapeutics area, endpoints and associated regulatory guidances
• Excellent written and oral English communication skills.

Physical Demands

While performing the duties of this job, the employee will need to safely navigate a traditional office with cubicles, offices and conference rooms.

Work Environment

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

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 $120,000 to $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. 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. 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.