Senior Director, Biostatistics

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Spyre Therapeutics

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11 - 50 Mitarbeiter

🧬 Biotechnologie

💊 Pharmazie

Biotechnology • Pharmaceuticals

Spyre Therapeutics ist ein biopharmazeutisches Unternehmen, das sich auf die Entwicklung von Therapien für entzündliche Darmerkrankungen (IBD) konzentriert. Das Unternehmen setzt sich dafür ein, erstklassige Antikörper, rationale therapeutische Kombinationen und präzise Immunologieansätze zu schaffen, um die Wirksamkeit und den Komfort der Behandlung für IBD-Patienten zu verbessern. Mit einem erfahrenen Team, das Behandlungen für verschiedene Krankheiten entwickeln und vermarkten kann, widmet sich Spyre Therapeutics der Verbesserung von Behandlungsoptionen und Ergebnissen für Patienten durch fortgeschrittene Forschung in der Immunologie. Das Unternehmen fördert ein kooperatives und innovatives Umfeld, um seine Mission zu erreichen, vielversprechende neue Behandlungsoptionen für IBD bereitzustellen.

Beschreibung

• Provide leadership and strategic input for clinical development programs assigned. • Responsible for statistical activities supporting clinical trials, including contributing to trial designs, authoring statistical sections of protocols, preparing statistical analysis plans, and reviewing and interpreting the analysis of clinical trial data. • Interact with internal and external cross-functional study teams, support interactions with Health Authorities globally, conduct ad-hoc analyses, and manage biometrics vendors in preparing analysis files, performing statistical analyses, and delivering analysis results and data files. • Lead the biometrics team including statistician, data manager, and statistical programmer at a program level. • Provide statistical input to strategic planning, study design, protocol development, sample size calculation, CRF, Results Interpretation, clinical study report, and address questions from regulatory agencies. • Promote research of advanced and innovative statistical methods to increase probability of success of clinical studies. • Author and develop SAPs, and work with extended team or vendor in developing specification for derived variables, templates of statistical tables, figures, and listings. • Provide guidance to study team on all aspects of statistical activities; collaborate closely with data manager to ensure high-quality data. • Participate in cross-functional study-related activities; work collaboratively with Clinical Development, Clinical Operations, Clinical Data Managers, Pharmacovigilance & Epidemiology, Regulatory, Project Management, Translational Medicine, and other staff and vendors to meet project deliverables and timelines. • Establish procedures through regular interaction, setting expectations on deliverables and timelines for CRO / Vendor Oversight. Ensure deliverables are accurate and delivered according to timelines. • Contribute to documents submitted to Health Authorities globally by providing input for the interaction or by writing the interaction document. May participate in meetings or teleconferences with Health Authorities. • Coordinate with internal and external team members to prepare the statistical analyses for IB, DSUR updates, periodic safety updates, and other ad hoc analyses. • Build and develop efficient biostatistical processes and standards. • Other duties as assigned.

🎯 Anforderungen

• PhD Degree in Biostatistics, Statistics, or a related field with at least 10-12 years of experience in biostatistics within the pharmaceutical, biotech, or CRO industry. • Strong knowledge of statistical methodologies and their application in clinical trials and health research. Working knowledge of Bayesian methodology and causal inference is preferred. • Experience with regulatory submissions and interactions with regulatory agencies. • Proficiency in statistical software (e.g., SAS, R) and data management systems. • Experience with CDSIC including SDTM, ADaM, CDASH. • Successful track record of working independently in a matrixed organization and providing solutions to emerging problems. • Excellent communication and interpersonal skills, along with organizational skills. • Ability to work collaboratively in a multidisciplinary team environment. • Experience in people management is preferred.

🏖️ Vorteile

• Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits. • Unlimited PTO • Two, one-week company-wide shutdowns each • Commitment to provide professional development opportunities. • Remote working environment with frequent in-person meetings to address complex problems and build relationships.