Biostatistician Contractor
:
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.
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