Senior Director – Biostats

🔥 1 minute ago

🇺🇸 United States – Remote

💵 $300k - $360k / year

⏰ Full Time

🟠 Senior

👔 Director

👻 Ghost score 4%

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GondolaBio

WebsiteLinkedInAll Job Openings

11 - 50 employees

Founded 2024

🏥 Healthcare

💼 Consulting

🏭 Manufacturing

💰 $300M Venture Round - GondolaBio on 2024-08

Healthcare • Consulting • Manufacturing

GondolaBio is a clinical-stage biopharmaceutical company launched in 2024 and affiliated with BridgeBio Pharma, focused on developing breakthrough therapeutics for patients with genetic diseases. The company uses a lean, decentralized approach to accelerate early-stage research and development across multiple modalities (including small molecules and oligonucleotide therapies) and is building a diverse pipeline targeting rare and underserved genetic conditions such as EPP/XLP with its lead program PORT-77. GondolaBio centers patient needs and aims to bring disease-modifying treatments more quickly to populations lacking approved therapies.

📋 Description

• Serve as lead statistician for GondolaBio’s ASO and siRNA assets • Own statistical strategy from first-in-human studies through proof-of-concept and pivotal trials • Develop and defend fit-for-purpose statistical analysis plans for small samples, placebo and open-label designs, and high inter-patient variability • Lead Bayesian go/no-go criteria, probability-of-success, and assurance calculations for portfolio and stage-gate decisions • Lead pivotal designs, confirmatory-evidence strategies, integrated summaries, NDA/BLA/MAA statistical sections, information-request responses, advisory committee preparation, and labeling claims • Conduct statistical due diligence for in-licensing and acquisition candidates • Apply rare-disease trial designs including delayed-start, crossover, n-of-1, master protocols, randomized withdrawal, and seamless Phase 1/2/3 designs • Design prospective natural-history protocols, registry partnerships, and regulatory-grade external-control data standards • Partner with clinical teams to define credible and regulatorily acceptable endpoints • Lead disease-progression model development to select endpoints, enrich populations, and project long-term benefit • Partner with Pharmacometrics and Clinical Pharmacology on MIDD work • Integrate external controls and real-world data using target-trial emulation, propensity scores, covariate balancing, quantitative bias and sensitivity analyses, Bayesian inference, and dynamic borrowing • Apply ML-based prognostic covariates for covariate adjustment • Identify and mitigate risks involving variability, missing data, and limited statistical power • Prepare statistical sections of INDs, FDA/EMA meeting documents, scientific advice documents, endpoint qualification opinions, pediatric extrapolation, and PIP/iPSP strategies • Support pre-IND, EoP2, and pre-NDA/BLA meetings and respond to agency questions • Build and lead biostatistics, statistical programming, and data-management organizations using hybrid in-house and FSP/FSO sourcing • Select and oversee vendors supporting clinical, translational, and nonclinical analytics and deliverables • Partner with Clinical Development, Clinical Pharmacology, Pharmacometrics, Regulatory, Clinical Operations, CROs, and vendors • Embed statistical considerations into protocols, CRF design, data management, and study conduct • Represent Statistics in cross-functional program-team meetings • Collaborate with nonclinical, translational, and clinical teams on PD biomarker, target-engagement, and patient-stratification analysis plans

🎯 Requirements

• Ph.D. in Biostatistics, Statistics, or a closely related field • 10+ years of pharmaceutical/biotech industry experience • Direct early-phase and late-phase rare disease development experience • Experience designing and analyzing high-variability clinical and neurological endpoints • Deep familiarity with rare-disease statistical challenges, including small sample sizes, open-label designs, natural-history controls, and high inter-patient variability • Hands-on proficiency with SAS and/or R • Ability to independently program and review analysis datasets and outputs • Experience authoring and defending SAPs, study reports, and regulatory-facing statistical documents • Comfort operating in lean, fast-paced biotech environments with autonomy and accountability • Familiarity with novel endpoints, multi-domain and composite endpoints, PRO/ClinRO, digital health technology endpoints, and psychometric validation in pediatric or rare-disease populations is a nice-to-have • Experience with AI/ML and data science is a nice-to-have • Experience with nonclinical, PK/PD, and pharmacometrics data programming and management is a nice-to-have • Patient-first, ethical, scientifically rigorous, entrepreneurial, collaborative, and execution-focused approach

🏖️ Benefits

• Patient Days • Culture inspired by company values • Decentralized model with reduced bureaucracy and empowered decision-making • Ownership of program vision and career path • Collaborative, fast-paced, data-driven environment • Learning and development resources • Market-competitive compensation and benefits package • Performance bonus • Equity • Health and welfare programs • Retirement programs • Flexible PTO • Rapid career advancement for strong performers • Potential ability to work on multiple GondolaBio Pharma programs across multiple therapeutic areas

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