Director of Biostats

Job not on LinkedIn

🕒 August 7

🇺🇸 United States – Remote

⏰ Full Time

🔴 Lead

👔 Director

👻 Ghost score 24%

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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 growing portfolio • 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 prospective in-licensing assets • Evaluate trial design quality, endpoint selection, and strength of signal, and flag statistical risks affecting 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 opportunities for AI and machine learning to improve statistical workflows • Work with clinical, medical, data architecture, clinical operations, regulatory, and business development teams

🎯 Requirements

• PhD in statistics or biostatistics with 10+ years' relevant pharma/biotech experience, or MS with 15+ years • Lead statistician experience across multiple Phase I/II programmes • Phase III and CSR experience a plus • Personal interaction with health authorities on at least one programme, including formal meetings or written correspondence • FDA preferred; EMA also considered • Adaptive trial design experience required • Experience setting statistical strategy at 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 a plus • Comfortable operating as both a leader and hands-on contributor • Excellent written and verbal communication skills across 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 for a Wellhub membership or wellness activities and expenses • 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 for courses, certifications, and development • Regular whole company and team events, both in person and virtually • Access to gym and retail discounts through Happl • Monthly lunch voucher for remote teams • Charity events and fundraising opportunities through the Forward Trust