Job Title: Biostatistician
Duration:12 Months
Location: Remote
Pay Rate: $103.44
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.