Senior Director, Statistical Programming

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Apogee Therapeutics

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51 - 200 Mitarbeiter

🧬 Biotechnologie

💊 Pharmazie

💰 €149.000.000 Series B im 2022-12

Biotechnology • Pharmaceuticals

Apogee Therapeutics ist ein biopharmazeutisches Unternehmen im klinischen Stadium, das sich auf die Entwicklung neuartiger Biologika zur Behandlung von Entzündungs- und Immunerkrankungen konzentriert. Das Unternehmen zielt auf bedeutende Märkte in den Bereichen entzündliche und immunologische Erkrankungen ab, wie z. B. atopische Dermatitis, Asthma, chronisch obstruktive Lungenerkrankung, eosinophile Ösophagitis und andere verwandte Zustände. Apogee Therapeutics strebt an, den aktuellen Behandlungsstandard zu verändern, indem es Antikörpertherapeutika vorantreibt, die auf etablierte biologische Mechanismen abzielen und das Potenzial haben, dermatologische, respiratorische und gastroenterologische Probleme zu adressieren. Das Unternehmen ist dazu verpflichtet, ein psychologisch sicheres Arbeitsumfeld zu schaffen, während es innovative Behandlungsoptionen für Menschen mit diesen Erkrankungen priorisiert.

Beschreibung

• 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

🎯 Anforderungen

• 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

🏖️ Vorteile

• 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