Associate Director Level BioStatistician

About the role

The Associate Director Level BioStatistician will lead statistical design, analysis, and interpretation for clinical trials across phases. They will develop statistical analysis plans and study protocols, ensuring high-quality deliverables for regulatory submissions.

Responsibilities

• Lead statistical design, analysis, and interpretation for clinical trials (Phase I–IV)
• Develop statistical analysis plans (SAPs) and study protocols
• Ensure high-quality statistical deliverables for submissions (FDA, EMA, etc.)
• Partner with clinical, regulatory, and medical teams to guide study design
• Provide input on endpoints, sample size calculations, randomization strategies
• Support regulatory submissions and health authority interactions
• Lead and mentor biostatisticians and/or programmers
• Oversee multiple studies or programs simultaneously
• Drive timelines, quality, and resource allocation
• Ensure integrity of clinical datasets, statistical outputs, TFLs (Tables, Listings, Figures)
• Review outputs from CROs or internal teams
• Work with clinical development, data management, statistical programming, and medical affairs teams
• Translate complex statistical findings into clear business/clinical insights

Requirements

• Education: PhD or Master’s in Biostatistics, Statistics, Mathematics, or related field (PhD often preferred for Associate Director level)
• Experience: 8–12+ years in pharma/biotech or CRO, strong experience in clinical trials (Phase II–III especially), regulatory submissions, prior leadership or mentoring experience
• Technical Skills: SAS (mandatory in most pharma roles), R / Python (increasingly preferred), strong knowledge of CDISC standards (SDTM, ADaM), ICH guidelines, GCP
• Preferred Skills: Experience with global regulatory interactions (FDA/EMA), oncology, CNS, or immunology therapeutic expertise, ability to handle multiple complex programs simultaneously, strong communication and stakeholder management