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Company

Original Job Post

Neurogene Inc. · 5 days ago

Senior Director, Biostatistics

New York, United States

Full-time

Onsite

Director

7+ years exp

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Biotechnology

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Responsibilities

Serve as a lead statistician and manage statistical efforts for clinical studies

Contribute to clinical protocol development, including authoring sections on statistical methods and reviewing/editing other sections, by applying statistical principles

Author statistical analysis plans for studies and/or ISS/ISEs, and author/edit tables, figures, and listings

Review CRF designs to ensure data collection meets the study objectives and the requirements of statistical analyses

Provide statistical input to independent data monitoring board charters, project management plans, and other study-level documents

Work with statistical programmers or CROs to generate tables, figures, and listings

Support ongoing safety review and data monitoring review of the clinical development program/study teams

Perform ad hoc and exploratory statistical analyses as needed

Contribute to clinical study reports, including authoring of statistical sections and interpretation of the study results

Support regulatory submissions as needed

Support the preparation of publications, including manuscripts, posters, and oral presentations

Provide oversight of CROs for outsourced statistical activities and QC key results generated by CROs

Qualification

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Clinical trial experiencePharmaceutical industry experienceClinical study designsProtocol draftingStatistical methodsPediatricsNeurologyRare diseasesGene therapyStatistical methods for clinical trialsFDA regulationsEMA regulationsICH guidelinesStatistical programmingSASRProject managementMetrics trackingProblem-solvingEffective communicationAnalyticalOrganizationalSelf-starterHigh energyInitiativeSelf-motivationFast-pacedSense of urgencyPassionateCollaborative

Required

PhD in biostatistics, mathematics, statistics, public health, or related discipline, with at least 7 years of relevant clinical trial experience

MS in biostatistics, mathematics, statistics, public health, or related discipline, with at least 9 years of relevant clinical trial experience

7-9 years of substantive experience in the pharmaceutical/biotechnology industry

In-depth understanding of clinical study designs, drafting protocols, authoring statistical methods sections in Regulatory documents

Experience in pediatrics, neurology, rare diseases and/or gene therapy and small trial designs would be ideal

Deep knowledge of statistical methods for clinical trials

Knowledge of FDA, EMA and ICH regulations and guidelines

Proficient in statistical programming (SAS is required and R is a plus)

Effective communication skills and ability to work with cross-functional study teams

Excellent analytical and problem-solving skills

Strong organizational skills and ability to deliver professional and quality work products, while working on multiple projects in an extremely fast-paced environment

Continuous strong focus on meeting or exceeding expectations in executing deliverables, performance and results.

Ability to track and measure performance against defined metrics.

Self-starter with high degree of energy, independence, initiative and self-motivation, as illustrated by the ability to instill a sense of pace and urgency into the team

Someone who moves fast and decisively in a balanced manner, with a passion for the growing company

Passionate, collaborative, creative, willing to take prudent risks, and motivated by the creation of a company focused on transformative treatments for patients and their families