Job Summary: We are seeking a highly skilled and experienced Senior Biostatistician to join our clients dynamic team. The successful candidate will play a critical role in the design, analysis, and interpretation of clinical trials and other research studies, with a specific focus on diabetes. This position requires a deep understanding of biostatistics, strong analytical skills, and the ability to work collaboratively with cross-functional teams. The role offers a hybrid working arrangement, requiring onsite presence in the San Francisco area.
Key Responsibilities:
- Protocol Development: Collaborate with clinical and research teams to develop study protocols, ensuring statistical integrity and scientific validity.
- Statistical Analysis: Perform complex statistical analyses for clinical trials and other research studies, using advanced statistical methods and software.
- Study Design: Design clinical trials and observational studies, including sample size calculations, randomization schemes, and statistical analysis plans.
- Data Management: Oversee data collection, management, and quality control processes to ensure accuracy and completeness of data.
- Reporting: Prepare detailed statistical reports, manuscripts, and presentations for internal and external stakeholders, including regulatory agencies.
- Collaboration: Work closely with clinical researchers, data managers, and other stakeholders to provide statistical expertise and support throughout the study lifecycle.
- Regulatory Compliance: Ensure all statistical activities comply with regulatory requirements and guidelines, including GCP, ICH, and FDA standards.
- Mentorship: Provide guidance and mentorship to junior biostatisticians and other team members.
Qualifications:
- Education: Ph.D. or Master’s degree in Biostatistics, Statistics, or a related field.
- Experience: Minimum of 8 years of experience in biostatistics, with direct experience in diabetes research or clinical trials.
- Skills: Proficiency in statistical software (e.g., SAS, R), strong analytical and problem-solving skills, excellent written and verbal communication skills.
- Knowledge: In-depth knowledge of clinical trial design, statistical methodologies, and regulatory requirements.
