Biostatistician

Job Description

Job Summary:

• The role is responsible for conducting biostatistical activities to support all phases of clinical development and post-marketing efforts.
• This role will collaborate closely with other biostatisticians, statistical programmers, and cross-functional team members, as well as with contract research organization (CRO) partners and other vendors to meet company R&D objectives.
• Individuals in this role will support the development and review of statistical deliverables and provide high-quality analytical outputs to inform clinical and regulatory decision-making.

Education and Experience:

• Master’s Degree in statistics, biostatistics from accredited college or university
• Minimum 4 years of experience within the biotech/pharmaceuticals industry or a related field.
• Experience in statistical responsibilities for design, analysis, and reporting of randomized controlled trials.

Knowledge, Skills, and Abilities:

• Strong understanding of clinical trial design principles, including adaptive designs.
• Ability to effectively communicate complex statistical analyses and concepts to non-statisticians in non-technical language.
• Ability to balance scientific rigor with operational and business considerations in a fast-paced development environment.
• Knowledge and extensive hands-on experience with CDISC methodologies and industry data standards including SDTM and ADAM.
• Demonstrated ability to manage multiple priorities and timelines while delivering high-quality outputs.
• Working knowledge of regulatory guidelines and expectations in pharmaceutical development; experience supporting regulatory interactions is a plus.
• Programming experience in SAS is required; experience in R is a plus.
• Familiarity with real-world evidence and observational research methodologies (e.g., causal inference) is a plus.
• Prior experience supporting clinical development programs in acute or chronic pain indications is a plus.
• Understanding of standard operating procedures, process and quality control associated with biostatistics in the pharmaceutical industry.