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Jobs · Analyst · New Jersey

Associate Director, Late Phase Research Biostatistics

Pacira BioSciences, Inc. · Parsippany, NJ · 2 wk ago
On-siteAnalyst$141k–$194k/yrFull-time

About the role

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

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 projects.
  • Conduct statistical analyses, prepare statistical methods and results sections for clinical study reports (CSR), and produce overall summaries.
  • Review and approve key results memos and statistical conclusions.
  • Provide guidance to clinical and cross-functional teams regarding conclusions and inferences from the data package.
  • Ensure statistical representation at cross-functional or external meetings.
  • Deliver completed data packages relevant for publication or key decision-making.
  • Ensure statistical deliverables are 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).
  • Ensure consistency of data collection and analysis across projects or areas.
  • Produce analysis datasets that are quality controlled, sufficient to generate TLG for reports, and consistent within projects.
  • Plan and track project activities, timelines, and resource use across projects; provide justification for planned resource needs.
  • Optimize resource utilization and capacity.
  • Mentor and develop staff, encouraging personal development in the context of project work.
  • Learn and apply techniques to promote teamwork, quality, and motivation; manage conflict.
  • Maintain awareness of industry standards, regulatory requirements, and departmental guidelines and SOPs; update procedures or practices as needed to remain in compliance.
  • Serve as departmental representative on division or corporate-wide teams; advocate application of statistical thinking in decision-making.
  • Supervise 1-3 direct reports.

Requirements

  • Ph.D. or master’s degree in Biostatistics or closely related discipline from an 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 highly preferred but not required.
  • Demonstrated leadership, project management, and interpersonal skills.
  • Excellent written and verbal English communication skills.
  • Excellent presentation skills to groups of varied size and composition.
  • Demonstrated broad knowledge and superior understanding of advanced statistical concepts and techniques.
  • 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 approximately 20% (overnights required).

Benefits

  • Medical, Prescription, Dental, and 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

The base pay range for this role is $141,000 to $194,000 per year. The range considers factors including 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.

Schedule

  • Ability to travel approximately 20% (overnights required).

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 healthcare facilities.

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 consists of a typical pharmaceutical office environment with offices and cubicles.

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