EPM Scientific
About the Role
As Director of Biostatistics, you will provide strategic leadership for statistical design and analysis across all phases of clinical development. This is a highly visible role, partnering closely with clinical, regulatory, and data science teams to shape trial strategy, ensure regulatory compliance, and deliver high-quality statistical insights that drive decision-making. You\'ll also play a key role in developing departmental standards and guiding interactions with global health authorities.
Responsibilities
Lead statistical strategy and execution for clinical trials across multiple phases.
Author and review statistical analysis plans, protocols, and regulatory submissions.
Collaborate cross-functionally to ensure robust trial design and data integrity.
Provide statistical guidance during regulatory interactions and advisory meetings.
Oversee vendor relationships, timelines, and deliverables for outsourced statistical work.
This role does not have supervisory responsibilities
Qualifications
Advanced degree (PhD/MS) in Biostatistics or related field.
Hands‑on leadership supporting oncology clinical trials within biotech/pharma.
Preferred: Direct leadership of at least one Phase III study.
10+ years of experience in clinical trial statistics within biotech/pharma, with oncology strongly preferred.
Proven track record in late-phase trial leadership and regulatory submissions (FDA/EMA).
Expertise in CDISC standards and statistical software (SAS, nQuery, etc.).
Strong communication skills and ability to influence cross-functional teams.
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Responsibilities
Lead statistical strategy and execution for clinical trials across multiple phases.
Author and review statistical analysis plans, protocols, and regulatory submissions.
Collaborate cross-functionally to ensure robust trial design and data integrity.
Provide statistical guidance during regulatory interactions and advisory meetings.
Oversee vendor relationships, timelines, and deliverables for outsourced statistical work.
This role does not have supervisory responsibilities
Qualifications
Advanced degree (PhD/MS) in Biostatistics or related field.
Hands‑on leadership supporting oncology clinical trials within biotech/pharma.
Preferred: Direct leadership of at least one Phase III study.
10+ years of experience in clinical trial statistics within biotech/pharma, with oncology strongly preferred.
Proven track record in late-phase trial leadership and regulatory submissions (FDA/EMA).
Expertise in CDISC standards and statistical software (SAS, nQuery, etc.).
Strong communication skills and ability to influence cross-functional teams.
#J-18808-Ljbffr