Remote, Senior Biostatistician, Biotechnology

Job Title: Senior Biostatistician

Location: Remote

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; Data Standards: regulatory submission/support experience preferred.

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.

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.

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; Familiarity with real-world evidence and observational research methodologies (e.g., Understanding of standard operating procedures, process and quality control associated with biostatistics in the pharmaceutical industry.

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.