Biostatistician

Duration: 6 Months

Location: Parsippany, NJCandidates may be required to work onsite for a few days during the assignment, with the remaining time being fully remote.

Job Description: 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 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.