Senior Director, Statistical Programming

🕒 Abril 30

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Apogee Therapeutics

SiteLinkedInTodas as Vagas

51 - 200 funcionários

🧬 Biotecnologia

💊 Farmacêutico

💰 $149.000.000 Series B em 2022-12

Biotechnology • Pharmaceuticals

Apogee Therapeutics é uma empresa de biotecnologia em fase clínica focada no desenvolvimento de novos biológicos para o tratamento de distúrbios inflamatórios e imunológicos. A empresa mira mercados principais em doenças inflamatórias e imunológicas como dermatite atópica, asma, doença pulmonar obstrutiva crônica, esofagite eosinofílica e outras condições relacionadas. A Apogee Therapeutics busca reformular o padrão atual de cuidados ao avançar terapias com anticorpos que visam mecanismos biológicos bem estabelecidos, com potencial para atender questões dermatológicas, respiratórias e gastroenterológicas. A empresa está comprometida em criar um ambiente de trabalho psicologicamente seguro enquanto prioriza opções de tratamento inovadoras para aqueles que vivem com essas condições.

Descrição

• Support the statistical programming function by implementing programming processes, standards, and SOPs for clinical trials • Contribute to the development and maintenance of SAS programming infrastructure, processes, and data standards • Lead programming activities for assigned projects and studies (e.g. leading submission), ensuring timely and high-quality deliverables • Manage and oversee CROs and external vendors to ensure quality and compliance with expectations • Collaborate closely with Biostatistics, Data Management, Clinical Operations, Regulatory, Pharmacovigilance, and other functions • Develop and implement data review, reporting tools, and statistical applications in partnership with cross-functional teams • Review and validate SAS programs (SDTM, ADaM, and TFLs) generated internally or by CROs • Review SAPs, DMPs, CRFs, annotated CRFs, TFL specifications, and other study documents, providing expert programming input • Mentor and develop programmers, fostering a high-performing and collaborative team environment • Provide hands-on support for complex analyses and ad hoc requests as needed • Drive process improvements and efficiencies, including the adoption of automation and AI-based solutions in programming workflows

🎯 Requisitos

• Master's Degree in Statistics, Biostatistics, Mathematics, Computer Science, or a related field • A minimum of 12–15 years of progressive clinical trial programming experience in the biotech/pharma industry, including leadership experience • Advanced SAS programming skills: experience with R or other statistical programming languages preferred • Strong experience and in-depth knowledge of CDISC standards (SDTM, ADaM) and controlled terminology • Experience supporting regulatory submissions (e.g., NDA/BLA/MAA) • Knowledgeable in AI use in drug development and ambitious in leveraging AI to build infrastructure/workflows to expedite submission process • Excellent organizational skills with the ability to manage multiple priorities • Strong communication and interpersonal skills, with the ability to collaborate cross-functionally • Experience managing CROs and external data vendors • Demonstrated ability to mentor team members and contribute to team development • Advanced knowledge of statistical programming methodologies in clinical study settings • Knowledge of ICH guidelines and FDA / EMA / other regulatory authority requirements • Experience working in a fast-paced, growth-oriented environment • Experience working in a remote/virtual environment • Experience with AI-driven tools or automation in clinical data analysis and regulatory submission processes (e.g., AI-assisted generation, validation, or review of submission deliverables) • Familiarity with modern data platforms, cloud environments, or scalable analytics infrastructure • Experience in a small to mid-size biotech environment • Strong leadership with a collaborative and growth-oriented mindset • High attention to quality and detail • Adaptability and ability to operate effectively in a fast-moving environment • Commitment to fostering a psychologically safe and inclusive team culture • Alignment with Apogee’s C.O.R.E. values: Caring, Original, Resilient, and Egoless • Position requires up to 15% travel including mandatory in-person attendance at All Hands meetings typically held twice per year

🏖️ Benefícios

• A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless • Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly • Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits • We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave • Commitment to growing you professionally and providing access to resources to further your development • Apogee offers regular all team, in-person meetings to build relationships and problem solve