Biostatistician Contractor

Job Description:

Position Summary

Principal Duties and Responsibilities include the following:

• Provide statistical input into the design, analysis, and interpretation of Phase 3 clinical trials.
• Collaborate with cross-functional teams (clinical, data management, programming, medical writing) to ensure statistical deliverables meet project timelines and quality standards.
• Contribute to the development of statistical analysis plans (SAPs), table/figure/listing (TFL) shells, and statistical programming specifications.
• Review and interpret clinical trial data, generating summary reports for internal decision-making and regulatory submissions.
• Support Real-World Evidence studies, including study design, methodology, and statistical analyses.
• Review protocols, CRFs, and other study documents to ensure statistical integrity and regulatory compliance.
• Collaborate with external vendors/CROs to oversee statistical programming and analyses.
• Participate in responses to regulatory agency queries and prepare statistical sections for submission documents.

Qualification Requirements:

• Master's or Ph.D. in Biostatistics, Statistics, or related discipline.
• Minimum 7 years of experience as a biostatistician in the pharmaceutical or biotech industry with a PhD degree or minimum of 10 years experience with a master degree.
• Strong knowledge of statistical methodologies such as survival models, mixed models etc.
• Demonstrated expertise in Phase 3 clinical trial design, conduct, and analysis.
• Strong knowledge of ICH guidelines, CDISC standards (SDTM, ADaM), and regulatory submission requirements.
• Experience with Real-World Evidence (RWE) studies preferred.
• Prior work in retinal diseases or ophthalmology preferred.
• Proficiency in SAS (required); experience with R is a plus.
• Strong problem-solving, organizational, and communication skills.
• Ability to work independently and manage multiple priorities in a fast-paced environment.