Senior Manager, Biostatistics

Pacira Pharmaceuticals, Inc.•Parsippany-Troy Hills, NJ

6d•Onsite

About The Position

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.

Requirements

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.
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.

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