Associate Director – Director, Statistical Programming

Emploi pas sur LinkedIn

🕒 il y a 3 jours

🇺🇸 États-Unis – Télétravail

⏰ Temps Plein

🟠 Senior

👔 Directeur

🦅 Parrain de Visa H1B

Cette entreprise a parrainé des visas H1B par le passé.

👻 Score fantôme 12%

Ce que ça veut dire : la probabilité que personne ne recrute vraiment pour cette offre.Comment le lire : 60 % ou plus, on pense que c'est une offre fantôme. Un score plus bas est moins inquiétant.Comment on la calcule : ancienneté, republications, postes ouverts vs taille de l'équipe, rapidité de clôture, et si le salaire est indiqué.À noter : une estimation à partir de données publiques, pas un jugement sur l'entreprise. De vraies offres peuvent avoir un score élevé, alors prenez-le comme un indice, pas comme un fait.

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MeiraGTx

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51 - 200 employés

🧬 Biotechnologie

🏥 Santé

💊 Pharmaceutique

Biotechnology • Healthcare • Pharmaceuticals

MeiraGTx est une société de médecine génétique intégrée verticalement, au stade clinique, qui se consacre au développement de thérapies géniques pour différentes pathologies, notamment les maladies rares et neurodégénératives. L’entreprise dispose de solides capacités en matière de conception et d’optimisation de vecteurs viraux, et exploite deux sites de production de vecteurs viraux conformes aux BPF (GMP), ainsi que son propre centre de contrôle qualité. MeiraGTx s’appuie sur des technologies innovantes, telles qu’une plateforme de régulation génique fondée sur les riboswitches, afin de contrôler précisément l’expression des gènes. Son objectif est d’améliorer l’administration de peptides métaboliques et d’étendre les applications de la médecine génétique au-delà des pathologies oculaires pour répondre à d’importants besoins médicaux non couverts dans diverses aires thérapeutiques.

Description

• Provide technical and operational leadership for statistical programming across clinical studies and development programs • Ensure the quality, accuracy, timeliness, traceability, and regulatory readiness of programming deliverables • Lead delivery of SDTM and ADaM datasets, tables, listings, figures, define.xml, reviewer guides, integrated analyses, exploratory analyses, and responses to regulatory questions • Provide hands-on leadership in a growing biotechnology environment • Provide strategic oversight of CROs and contractors • Partner effectively with cross-functional teams • Develop scalable standards, automation, and fit-for-purpose processes • Lead clinical programming and regulatory submission activities • Support quality, compliance, and inspection readiness • Manage strategic planning and risk management • Oversee CROs and vendors • Influence cross-functional stakeholders and solve technical problems • Travel up to 10–15% based on business needs • Provide flexibility during database locks, major submission milestones, or urgent regulatory responses

🎯 Exigences

• Bachelor’s or advanced degree in Statistics, Biostatistics, Mathematics, Computer Science, Data Science, Life Sciences, or a related quantitative discipline • At least 10 years of statistical programming experience in the pharmaceutical, biotechnology, or CRO industry • Demonstrated study or program leadership, BLA/NDA/MAA submission experience, vendor oversight, and functional or people leadership • Advanced SAS programming skills, including SAS/BASE, SAS Macro, SAS SQL, ODS, and programming for clinical data analysis and reporting • Advanced knowledge of CDISC standards, including SDTM, ADaM, controlled terminology, define.xml, and associated implementation guidance • Experience producing and overseeing programming deliverables for clinical study reports and regulatory submissions • Working knowledge of the clinical drug-development process, clinical trial methodology, statistical concepts, GCP, ICH guidance, and electronic submission expectations • Experience with data and submission validation tools such as Pinnacle 21 and resolving validation findings in a documented, risk-based manner • Ability to manage multiple priorities, anticipate risks, negotiate realistic timelines, and deliver high-quality work in a fast-paced environment • Excellent written and verbal communication skills, sound judgment, attention to detail, and ability to influence effectively in a cross-functional matrix • Hands-on experience with global regulatory submissions, including NDA, BLA, MAA, or equivalent submissions, integrated summaries, information requests, inspections, and post-submission analyses • Experience in rare disease, gene therapy, ophthalmology, or another complex clinical-development setting • Experience with R and relevant clinical-development ecosystems; familiarity with Python, XML, Git, or metadata-driven reporting is an advantage • Experience building or governing reusable programming infrastructure, macro libraries, automated QC frameworks, and reproducible reporting workflows • Experience authoring or implementing SOPs, work instructions, programming standards, and vendor governance processes • Familiarity with validated cloud or collaborative programming environments and responsible use of AI-assisted programming tools • Preferred US Eastern Standard Time zone availability

🏖️ Avantages

• Remote work arrangement • Travel up to 10–15% based on business needs • Flexibility during database locks, major submission milestones, or urgent regulatory responses

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