Clinical Research Statistician
5 days ago
Key Responsibilities
- Study Design & Statistical Planning: Collaborate with clinical teams to design studies, including sample size calculations, randomization plans, and statistical methodology to ensure scientifically sound trials.
- Statistical Analysis: Perform and oversee statistical analyses of clinical trial data, ensuring adherence to regulatory standards and industry best practices.
- Data Interpretation: Work with clinical teams to interpret statistical results and provide insights to support clinical conclusions.
- Statistical Programming: Develop, validate, and maintain statistical programs using SAS or other software to support data analysis and reporting.
- Regulatory Support: Prepare statistical sections of clinical trial protocols, statistical analysis plans (SAPs), and contribute to regulatory submissions.
- Collaboration & Communication: Provide statistical input to cross-functional teams and communicate statistical findings clearly to stakeholders.
- Quality Assurance: Ensure data integrity and accuracy, conduct quality control checks, and adhere to Good Clinical Practice (GCP) guidelines and SOPs.
Qualifications
- Education: Master's or Ph.D. in Biostatistics, Statistics, or a related field.
- Experience: 3+ years of experience in clinical trial biostatistics, preferably within a CRO or pharmaceutical setting.
- Technical Skills: Proficiency in statistical software such as SAS, R, or similar tools. Experience with CDISC standards (SDTM, ADaM) is preferred.
- Regulatory Knowledge: Familiarity with FDA, EMA, and ICH guidelines as they relate to statistical practices in clinical research.
- Communication Skills: Ability to communicate complex statistical concepts to stakeholders.
- Team-Oriented: Ability to work effectively in a collaborative team environment.
Benefits
- Competitive salary and benefits package.
- Flexible work schedule.
- Opportunities for career growth and continuing education.
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