Senior Biostatistician
Cynet systems Inc, Durham, NC, United States
Job Overview
Responsibilities
- Collaborate with cross-functional teams to drive statistical planning, analysis, and reporting for clinical development and regulatory submissions.
- Serve as a key resource to the biostatistics function, ensuring scientific integrity and regulatory compliance.
- Act as lead statistician on major projects, contributing to clinical development strategies and internal decision-making.
- Support regulatory interactions and respond to statistical queries from health authorities.
- Lead statistical input for submission activities including Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (Client).
- Develop and refine Statistical Analysis Plans (SAPs) in collaboration with clinical and biostatistics stakeholders.
- Provide statistical input into protocol design, amendments, and study documentation.
- Ensure rigor and appropriateness of statistical methodologies across studies.
- Monitor blinded study data to identify trends, inconsistencies, and potential data quality issues.
- Mentor and guide biostatistics and programming teams to align with standards and expectations.
- Coordinate with statistical programming teams to execute dry runs and prepare for database lock and final analysis.
- Review and validate statistical outputs including Tables, Listings, and Figures (TLFs) and final study reports.
- Support interpretation of statistical results and enable data-driven decision-making.
- Prepare materials, perform exploratory analyses, and troubleshoot statistical or data-related issues.
- Facilitate communication between stakeholders to ensure alignment and timely delivery.
- Ensure all deliverables meet quality standards and comply with regulatory requirements such as ICH-GCP, FDA, and EMA guidelines.
- Maintain adherence to established processes, templates, and documentation standards.
Required Qualifications
- MS or PhD in Biostatistics or related field.
- 8+ years of experience in the life sciences or pharmaceutical industry.
- Expertise in statistical methods for Phase 2–3 clinical trials.
- Strong experience collaborating with clinical and drug development teams.
- Proven experience supporting regulatory submissions including datasets, eCTD, and health authority interactions.
- In‑depth knowledge of GCP and ICH guidelines.
- Strong proficiency in SAS or R.
- Experience with CDISC data standards.
- Excellent communication, collaboration, and problem‑solving skills.
- Ability to work independently and proactively.
Preferred Qualifications
- Experience in rare disease or immunology studies.