About the Role
We are seeking a Biostatistician II to provide statistical expertise in the design, analysis, and interpretation of clinical studies. This role supports project teams across multiple phases of drug development, ensuring that statistical methodologies are appropriately applied and that study results are accurately reported. The Biostatistician collaborates closely with cross-functional teams including clinical, data management, and programming, and may contribute to regulatory submissions and publications.
Requirements
Experience:
2-4 years of experience.
Pharmaceutical, CRO, or related industry experience with clinical trials.
Technical Skills:
Proficient in SAS and/or R; familiar with CDISC standards.
Strong programming skills; experience in clinical trial datasets.
Strong oral and written communications skills, with the ability to effectively communicate internally and with clients.
Education: Ph.D. or Master’s in Biostatistics, Statistics, or a related field.
Knowledge: Experience with protocol/statistical analysis plan (SAP).
Soft Skills: Problem solving, time management.
Qualification
Excellent written and verbal communication skills, with the ability to convey complex statistical concepts to non-statistical audiences.
Strong understanding of clinical trial design and regulatory requirements.
Familiarity with statistical software packages and tools.
Responsibilities
Design, implement, and analyze clinical trial data using advanced statistical techniques.
Develop and validate statistical models to interpret complex datasets and inform study designs.
Collaborate with clinical and regulatory teams to ensure compliance with statistical standards and guidelines.
Review and provide guidance on statistical analysis plans, including sample size calculations and randomization methods.
Support the preparation of regulatory submissions and publications.