Senior Director of Biostatistics
L
Lindus TherapeuticsBiopharma
Location: US; Workplace: RemoteFull-TimeDirector
Salary not disclosed
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Job Details
- Experience
- 10+ years' relevant pharma/biotech experience with a PhD, or 15+ years with an MS
- Required Skills
- R
Requirements
- PhD in statistics or biostatistics with 10+ years of relevant pharma/biotech experience, or an MS with 15+ years.
- Lead statistician experience across multiple early-phase programmes, including at least one programme through CSR.
- Experience interacting personally with health authorities on multiple programmes, including formal meetings and written correspondence; FDA preferred and EMA also considered.
- Experience with adaptive trial design.
- Experience setting statistical strategy at programme or portfolio level.
- Strong knowledge of CDISC standards, regulatory submission requirements, and current drug development trends.
- Strong programming skills, including the ability to independently generate analysis output.
- R and/or SAS fluency preferred; familiarity with applying AI/ML tools to statistical workflows is a plus.
- Experience evaluating external clinical data through due diligence, licensing, or M&A activity is strongly preferred.
- Track record of hiring, managing, and developing statisticians; experience building or scaling a biostatistics function is preferred.
- Ability to contribute hands-on as well as lead, with written and verbal communication skills across executive, technical, and non-technical audiences.
Responsibilities
- Set statistical strategy across the growing portfolio and lead the biostatistics, statistical programming, and medical writing functions.
- Set team priorities, ways of working, hiring plans, and SOPs.
- Lead statistics on active and incoming programmes from protocol development through database lock and clinical study report.
- Author and review SAPs, sample size and power calculations, and randomisation schemes.
- Review statistical output at key milestones, including interim analyses and DSMB packages.
- Represent the statistical function in regulator meetings, briefing documents, and responses to health authority queries.
- Author and review statistical sections of regulatory submissions, including IND and NDA filings.
- Assess clinical data packages for in-licensing targets, including trial design, endpoint selection, and strength of signal.
- Oversee statistical programming deliverables and medical writing output for CSRs and submissions.
- Evaluate external CRO/FSP partnerships and identify useful applications of AI and machine learning in statistical workflows.
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