About the position
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, hands-on SR. Director/Director, Biostatistics. This is an individual contributor role with the potential to lead and manage a small team in the future. Title commensurate with experience.
Responsibilities
- Provides expert statistical input in design and analysis of clinical trials and other research studies. ,
- Develops, reviews and provides input on statistical analysis plans for study documents, protocols, amendments and New Drug Applications (NDAs)/ Marketing Authorization Application (MAAs) ensuring scientific, statistical and regulatory standards. ,
- 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. ,
- Translates statistical thinking into strategic input and recommendations; ensures statistical integrity of deliverables and provides statistically sound scientific methodology input to meet project objectives, regulatory statistical and data requirements and timelines. ,
- Collaborates with clinical researchers, data managers and other stakeholders to ensure data quality and compliance with regulatory requirements. ,
- 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, etc. ,
- Contributes and, when appropriate, leads departmental initiatives focused on process building, process improvement and integration of new technologies to enhance efficiency and consistency across organization. ,
- 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
- Advanced degree (MS, PhD, etc.) in Biostatistics, Statistics or related field and minimum 12 years Clinical Biostatistics experience in positions of increasing technical and leadership responsibility in the pharmaceutical, biotechnology, healthcare or related industry. ,
- Strong, current working knowledge of regulatory requirements and guidelines for clinical trials (i.e., clinical study designs, statistical analysis techniques, regulatory expectations, etc.). ,
- Ability and experience balancing hands-on statistical expertise with high-level strategic collaboration. ,
- Hands on experience with data management, programming and quality assurance processes. ,
- Experience as lead statistician including, managing and prioritizing multiple projects/timelines, overseeing small teams and contributing to strategy discussions in cross functional settings. ,
- Experience interacting with the FDA and other regulatory organizations. ,
- Hands-on experience with statistical design and analysis of pain, addiction and/or Attention Deficit Hyperactivity Disorder (ADHD) clinical trials - PREFERRED.
Nice-to-haves
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Benefits
- Highly competitive compensation and benefits package.