Duration: 07 Months—Possible extension
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.
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.
About US Tech Solutions: US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit .
US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
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