Datawise Inc · 6 hours ago
Contractor - Associate Director Statistician - remote
United States
Contract
Remote
Lead/Staff
5+ years expDatawise Inc is seeking an Associate Director Statistician to lead biostatistical efforts on clinical development teams. The role involves providing strategic statistical input, designing and analyzing clinical trials, and ensuring high-quality deliverables through collaboration with various departments.
Biotechnology
No H1B
Responsibilities
Serve as the lead biostatistics representative on cross-functional clinical development teams, providing strategic statistical input across all phases of drug development
Partner closely with Clinical Development, Medical Affairs, Regulatory Affairs, Statistical Programming, Data Management, Medical Writing, and Preclinical teams to design, analyze, and interpret clinical trials
Lead the statistical design and analysis strategy for clinical studies, including sample size justification, endpoint selection, and statistical methodology
Author and review statistical analysis plans (SAPs), protocol sections, and key outputs such as tables, figures, and listings (TFLs)
Provide statistical leadership for regulatory interactions, including health authority meetings, advisory committee presentations, and responses to regulatory questions
Contribute to and lead process improvement initiatives, technical working groups, and cross-functional governance teams; establish timelines and ensure high-quality deliverables
Evaluate and implement innovative statistical methodologies and assess the suitability of statistical software and tools for complex analyses
Analyze and interpret time-to-event, longitudinal, and complex clinical data, ensuring robust and defensible conclusions
Prepare and deliver presentations and written reports to project teams, senior management, and external stakeholders; co-present key findings when appropriate
Participate in methodological research and innovation to advance statistical approaches in clinical trial development
Provide statistical training and mentorship to non-statisticians and junior statisticians to promote data-driven decision-making
Qualification
Required
PhD in Statistics or Biostatistics with 5+ years of pharmaceutical or CRO industry experience or MS in Statistics or Biostatistics with 8+ years of relevant industry experience
Strong expertise in clinical trial design and statistical analysis methodologies
Proficiency in statistical software (e.g., SAS, R, or equivalent)
Knowledge of drug discovery and clinical development, including regulatory requirements
Proven leadership and influencing skills within cross-functional teams
Strong critical thinking, problem-solving, and decision-making abilities
Excellent written and verbal communication skills, including communication with regulatory agencies
Ability to manage multiple priorities and perform effectively in a fast-paced, collaborative environment
Preferred
Experience in Neuroscience therapeutic area
Company
Datawise Inc
Drawing from years of clinical research expertise, our proficient professionals specialize in top-tier services including clinical study design, data management, statistical analysis, and SAS/statistical programming.
11-50 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase