Sr. Biostatistician

Description

Tris Pharma, Inc. (www.trispharma.com) is a leading privately-owned U.S. biopharmaceutical company with a focus on development and commercialization of innovative medicines in ADHD, spectrum disorders, anxiety, pain and addiction addressing unmet patient needs. We have more >150 US and International patents and market several branded ADHD products in the U.S. We also license our products in the US and ex-US markets. We have a robust pipeline of innovative products spanning neuroscience and other therapeutic categories employing our proprietary science and technology.

Our science and technology make us unique, but it is our team members that set us apart; they are the engine fueling Tris' passion and innovation. Our colleagues understand the criticality of operating a successful business and take pride in the company's success. But of equal importance to each team member is how we interact with one another on a daily basis. We believe in each other and in respectful, open and honest communications to help support individual and team success.

We have an opening in our Monmouth Junction, NJ facility for an experienced SR. Biostatistician. This is an individual contributor role with potential to lead and manage a small team in the future.

The Senior Biostatistician provides advanced statistical expertise and leadership in the design, analysis, and interpretation of clinical trials and other health-related research. Incumbent plays a crucial role in advancing the company's research objectives and improving patient outcomes by collaborating closely with cross-functional teams to ensure data accuracy and integrity, contributing to research protocol development and supporting regulatory submissions.

• Provides statistical input in design and analysis of clinical trials and other research studies

• Develops and reviews statistical analysis plans for study protocols, amendments and New Drug Applications (NDAs)/ Marketing Authorization Application (MAAs)

• Performs statistical analyses using advanced methods and software (i.e., SAS, R, etc.)

• Interprets and reports results of statistical analyses, ensuring accuracy, consistency and clarity

• Collaborates with clinical researchers, data managers and other stakeholders to ensure data quality and compliance with regulatory requirements

• Contributes to preparation of clinical study reports, regulatory submissions and scientific publications

• Mentors and trains junior biostatisticians and other team members, as needed

• Stays current with industry standards and advancements in statistical methodologies and tools

• Provides statistical guidance and support to cross-functional teams including, but limited to: Clinical Development, Regulatory Affairs and Medical Writing

• Manages and oversees assigned biostatistics projects, as required, ensuring timely and accurate completion

• May potentially lead and develop a team of biostatisticians, providing guidance and support in their professional growth

Requirements

REQUIREMENTS

• Advanced degree (MS, PhD, etc.) in Biostatistics, Statistics or related field and minimum 10 years Clinical Biostatistics experience in positions of increasing technical and leadership responsibility in the pharmaceutical, biotechnology, healthcare or related industry

• Current working knowledge of regulatory requirements and guidelines for clinical trials
• Hands on experience with data management and quality assurance processes
• Experience interacting with FDA and other regulatory organizations
• Current, working knowledge of regulatory requirements and guidelines for clinical trials

• Experience with data management and quality assurance processes

• Ability to potentially lead and develop a team

• Hands-on experience with statistical design and analysis of pain, addiction and/or Attention Deficit Hyperactivity Disorder (ADHD) clinical trials PREFERRED

We are a HYBRID work environment requiring local candidates to be able to work majority of week in office. Non-local candidates must be able to come into office multiple times a month. This position also requires some domestic and international travel, on occasion.

Tris Pharma, Inc. offers a highly competitive compensation and benefits package. To build and enhance our diverse workforce, we encourage applications from individuals with disabilities, minorities, veterans, women, LGBTQ, etc. Tris Pharma, Inc. is an Equal Opportunity Employer. #LI-hybrid