Senior Director of Biostatistics

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🔥 1 minute ago

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

👔 Director

👻 Ghost score 10%

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Lindus

WebsiteLinkedInAll Job Openings

51 - 200 employees

🏥 Healthcare

🧬 Biotechnology

☁️ SaaS

💰 Grant - Lindus on 2025-04

Healthcare • Biotechnology • SaaS

Lindus is a next-generation contract research organization (CRO) that combines integrated clinical trial delivery with an AI-assisted trial operating system. They offer end-to-end trial services—including patient identification and enrollment, flexible site models, decentralized trial capabilities, and integrated services—under a milestone- and performance-based commercial model that ties payments to timelines and operational performance. Lindus emphasizes real-time visibility, a single accountable team for study design through database lock, and expertise across cardiometabolic, respiratory, psychiatry, women’s health, dermatology, and diagnostics. The company operates across the US, UK, and Europe with APAC partnerships and reports over 160 full-time staff and high enrollment performance (82% of Lindus trials completed enrollment on or ahead of proposed timelines in the past three years).

📋 Description

• Set statistical strategy across the portfolio as it grows • Lead the biostatistics, statistical programming, and medical writing functions, including priorities, ways of working, hiring, and SOPs • Personally 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 output at key milestones, including interim analyses and DSMB packages • Serve as the primary statistical voice with regulators through meetings, briefing documents, and responses to health authority queries • Author and review statistical sections of regulatory submissions, including IND and NDA filings • Assess statistical rigour of clinical data packages for assets under consideration for in-licensing • Evaluate trial design quality, endpoint selection, and strength of signal • Flag statistical risk that could affect development strategy or deal terms • Oversee statistical programming deliverables, including analysis datasets, tables, listings, and figures consistent with CDISC standards • Oversee medical writing output for CSRs and submissions • Evaluate external CRO/FSP partnerships where needed • Identify where AI and machine learning tools can improve statistical workflows • Work closely with clinical, medical, data architecture, clinical operations, regulatory, and business development colleagues • Build out biostatistics, statistical programming, and medical writing functions as the portfolio grows • Set team processes and standards

🎯 Requirements

• PhD in statistics or biostatistics with 10+ years' relevant pharma/biotech experience, or MS with 15+ years, including lead statistician experience across multiple early-phase programmes, including at least one programme through CSR • Personally interacted with health authorities on multiple programmes, ideally early-phase INDs (NDAs also acceptable), including formal meetings and written correspondence; FDA preferred, EMA also considered • Adaptive trial design experience required • Experience setting statistical strategy at a programme or portfolio level • Strong knowledge of CDISC standards, regulatory submission requirements, and current drug development trends • Excellent programming skills, including independently generating analysis output • R and/or SAS fluency preferred • Familiarity with applying AI/ML tools to statistical workflows a plus • Experience evaluating external clinical data through due diligence, licensing, or M&A activity strongly preferred • Track record of hiring, managing, and developing statisticians, ideally including building or scaling a biostatistics function • Comfortable operating as both a leader and a hands-on contributor • Excellent written and verbal communication skills across executive, technical, and non-technical audiences

🏖️ Benefits

• Competitive salary • Meaningful stock options • 27 days annual leave in addition to 11 National Holidays • Health insurance coverage through our PEO Trinet • $40 monthly wellness allowance, which you can spend on a wellhub membership, or wellness activities and expenses of your choice! • Enhanced Parental Leave: 16 weeks full pay for primary caregiver and 6 weeks full pay for secondary caregiver • $2,000 Learning and Development allowance each year to put towards courses, certifications, and development • Regular whole company and team events, both in person and virtually • Access to gym and retail discounts through our benefits platform Happl • Monthly lunch voucher for our remote teams • Charity events and fundraising opportunities through our charity partnership with the Forward Trust