Senior Biostatistician

Pay Range: $90 to $104/hr on W2

Location: Remote

Duration: 12+ Months

Job Requirements: Education: Master’s in Statistics/Biostatistics required.

Experience: 4+ years in Biotech/Pharma or related industry. Core: Hands-on clinical trial design, analysis & reporting, especially Randomized Controlled Trials (RCTs).Programming: SAS – REQUIRED; R is a plus. Data Standards: Strong hands-on CDISC, SDTM & ADaM experience. Experience supporting clinical development programs across phases; regulatory submission/support experience preferred. Experience working with statistical programmers, cross-functional teams, CROs/vendors. Ability to explain complex statistical concepts to non-statistical stakeholders. Quality/Operations: Pharma SOP, QC, and statistical deliverable experience.

Nice-to-Have: Pain/acute or chronic pain indication, RWE/observational studies/causal inference, and regulatory interactions.

Duties: 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.

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.