Sr. Director / Executive Director - Biostats

Location: Remote U.S. with periodic travel

About GondolaBio 

GondolaBio is a clinical-stage biopharmaceutical company focused on developing breakthrough therapeutics for genetic diseases. GondolaBio is an independent sister company to BridgeBio, originally carved out in 2024 after securing $300M in private financing from external investors. GondolaBio aims to leverage cutting-edge biological research to discover, create, test, and deliver transformative medicines to treat patients who suffer from genetic diseases. 

Who You Are 

You are an experienced biostatistician with deep expertise in rare disease clinical development across the full lifecycle, with Biometrics leadership oversight and a forward-looking regulatory and methods agenda. This role will report into the Chief Development Officer, and be accountable for the statistical and data strategy of the portfolio from FIH through registration and lifecycle management. You thrive in lean, cross-functional settings and bring both methodological rigor and pragmatic judgment to study design and analysis. You are energized by the challenge of extracting meaningful, credible signal from small, heterogeneous patient populations. 

Key Responsibilities 

Statistical leadership for Oligonucleotide programs: 

• Serve as the lead statistician for GondolaBio's ASO and siRNA  assets, owning statistical strategy from early FIH through proof-of-concept and pivotal trials. Develop and defend fit-for-purpose statistical analysis plans (SAPs) that account for small sample sizes, placebo and open-label designs, and high inter-patient variability. 
• Early signal detection and quantitative decision-making: lead Bayesian go/no-go criteria, probability of success, and assurance calculations for portfolio and stage-gate decisions.
• Pivotal design and registration: lead single-study-plus-confirmatory-evidence strategies, ISS/ISE and integrated summaries, NDA/BLA/MAA statistical sections, responses to information requests, advisory committee preparation and labeling claims
• Portfolio and business development: statistical due diligence on in-licensing and acquisition candidates. 

Clinical & Rare disease-adapted trial design: 

• Apply specialized methods appropriate for small N studies designs including delayed start, crossover and n-of-1, master protocols, randomized withdrawal and seamless Ph1/2/3
• Design prospective natural history protocols, registry partnerships, and data standards that make the data usable as regulatory-grade external controls.
• Partner with clinical colleagues to define scientifically credible and regulatorily acceptable primary and secondary endpoints. 
• Lead disease progression model development from natural history and registration trial data to choose endpoints, enrich populations and project long-term benefit; partner with Pharmacometrics in connecting to MIDD work with Clinical Pharmacology. 
• Integrate external controls and real-world data using target trial emulation, propensity-score and covariate-balancing methods, quantitative bias and sensitivity analyses, Bayesian primary inference and dynamic borrowing. ML-based prognostic covariates for covariate adjustment.
• Proactively identify and mitigate risks from high variability, missing data, and limited statistical power, communicating trade-offs clearly to program leadership. 

Global regulatory statistical leadership: 

• Prepare and contribute to statistical sections of INDs, , FDA/EMA meeting briefing and scientific advice documents, qualification opinions for novel endpoints or natural history tools, pediatric extrapolation, PIP/iPSP strategies. Support pre-IND , EoP2, pre-NDA/BLA meetings, and respond to agency questions on statistical methodology. 
• Build and lead biostat, statistical programming and data management organization, including hybrid in-house plus FSP/FSO sourcing model, vendor selection and oversight to support clinical, translational and nonclinical data analytics and deliverables. AI/ML and data science including automation in programming is a plus.

Cross-functional collaboration: 

• Partner closely with Clinical Development, Clinical Pharmacology, Pharmacometrics, Regulatory, Clinical Operations, and external CROs/vendors to ensure statistical considerations are embedded early in protocol development, CRF design, data management, and study conduct. Represent Statistics in cross-functional program team meetings. 
• Collaborate with Nonclinical and translational teams, and Clinical teams to develop analysis plans for PD biomarkers, target engagement endpoints, and patient stratification. 

Preferred Education & Experience 

• Ph.D. in Biostatistics, Statistics, or a closely related field. 
• 10+ years of pharmaceutical/biotech industry experience, with direct early-phase and late-phase rare disease development experience. 
• Demonstrated experience designing and analyzing high-variability clinical and neurological endpoints. 
• Deep familiarity with statistical challenges specific to rare disease: small sample sizes, open-label designs, natural history controls, and high inter-patient variability. 
• Hands-on proficiency with SAS and/or R; ability to program and review analysis datasets and outputs independently. 
• Experience authoring and defending SAPs, study reports, and regulatory-facing statistical documents. 
• Comfort operating in lean, fast-paced biotech environments with significant autonomy and accountability. 

Nice-to-Haves 

• Familiarity with development and validation of novel endpoints in multi-domain and composite endpoints, PRO/ClinRO, digital health technology endpoints, and psychometric validation in pediatric or rare disease populations. 
• Experience with AL/ML and data science
• Experience with nonclinical, PK/PD and pharmacometrics data programming and management

No matter your role at GondolaBio, successful team members are 

Patient Champions who put patients first, uphold strict ethical standards, and anchor decisions in clinical and scientific integrity. 

Entrepreneurial Operators who take ownership and drive toward practical solutions, while exercising sound judgment, respecting established processes, and aligning with teammates and leadership. 

Truth Seekers who are rigorous, detail-oriented, and intellectually honest—comfortable challenging assumptions, engaging with data, and updating their views based on evidence. 

Collaborative Thinkers who work effectively in data-driven, interdisciplinary environments; listen actively; and welcome questions, debate, and constructive challenge as essential to better decision-making. 

Individuals Who Inspire Excellence in themselves and those around them. 

High-quality Executors who deliver against goals and milestones with precision, accountability, and appropriate urgency—without compromising scientific rigor or team alignment. 

What We Offer 

• Patient Days, where we are fortunate to hear directly from individuals living with the conditions we are seeking to impact throughout the year and learn how we can improve our efforts 
• A culture inspired by our values: put patients first, think independently, be radically transparent, every minute counts, and let the science speak 
• An unyielding commitment to always putting patients first 
• A decentralized model that enables our program teams to focus on advancing science and helping patients. Our affiliate structure is designed to eliminate bureaucracy and put decision-making power in the hands of those closest to the science 
• A place where you own the vision – both for your program and your own career path 
• A collaborative, fast-paced, data-driven environment where we inspire ourselves and each other to always perform at the top of our game 
• Access to learning and development resources to help you get in the best professional shape of your life 
• Robust and market-competitive compensation & benefits package (Base, Performance Bonus, Equity, health, welfare & retirement programs) 
• Flexible PTO 
• Rapid career advancement for strong performers 
• Potential ability to work on multiple GondolaBio Pharma programs across multiple therapeutic areas over time 
• Commitment to Diversity, Equity & Inclusion 

The base pay range for this position is $300,000 to $360,000 per year. The actual compensation offered will be determined based on a number of job-related factors, including experience, skills, qualifications, and location. A bonus plan and equity will also be offered. 

GondolaBio ServiceCo is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. Employees of BridgeBio and all affiliated companies should work through their managers to inquire about and learn more about this role.

Fraud Alert: We are aware of employment scams where individuals pose as representatives of GondolaBio and make false use of our company name to defraud job seekers. To protect yourself, please note that our official corporate website is https://gondolabio.com/; our careers page is https://gondolabio.com/#careers; our LinkedIn page is https://www.linkedin.com/company/gondolabio/. Please visit these links for official information from GondolaBio. Communication from any other variant is fraudulent. GondolaBio does not conduct interviews via text message/messaging platforms, will not ask you to download anything as part of your interview, will never request any form of payment, provide upfront payments of any kind, and does not make job offers without interviews.