Key Responsibilities:
Statistical Design and Analysis:
- Spearhead the development of advanced statistical methodologies for oncology clinical trials.
- Craft and scrutinize statistical analysis plans to ensure precision and reliability.
Data Management:
- Oversee the meticulous collection, integration, and validation of pivotal clinical trial data.
- Institute rigorous quality control procedures to safeguard data accuracy and integrity.
Clinical Trial Support:
- Contribute strategic statistical insights for protocol development, encompassing sample size calculations.
- Collaborate closely with clinical teams to decipher study results and contribute to comprehensive clinical study reports.
Regulatory Submissions:
- Lead the preparation and meticulous review of statistical sections in regulatory submissions, ensuring strict compliance.
Collaboration and Communication:
- Engage seamlessly with cross-functional teams, presenting sophisticated statistical findings to internal and external stakeholders.
- Play a pivotal role in interfacing with regulatory authorities during critical interactions.
Qualifications:
Education:
- Master's or Ph.D. in Biostatistics, Statistics, or a related field.
Experience:
- Proven track record in designing and analyzing oncology clinical trials.
- Mastery of statistical software (e.g., SAS, R) and adeptness in data visualization tools.
Skills:
- Exemplary problem-solving skills with an unwavering attention to detail.
- Superlative communication skills, capable of elucidating complex statistical concepts.
