Associate Director, Biostatistics

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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

• Contributor on regulatory submissions • Provide expert statistical advice, methodological research and analysis of trial and epidemiological data to inform the design, planning and execution of Apogee’s clinical studies • Review and/or author statistical analysis sections of protocols, statistical analysis plans, clinical study reports, regulatory documents or scientific publications, generates or reviews study randomization, and sample size/power estimations • Oversee the vendor/CRO biostatistics teams, including activities during TFL development, Data Monitoring Safety Board meetings, interim analyses, and database locks • Execute or oversee individual projects, which will include meeting with project/study team members, conducting exploratory analyses and graphic support, and providing analyses for publications of Apogee’s studies • Evaluate alternative or innovative approaches to statistical methods and study design • Build relationships with CROs and other external partners to achieve results for specific project needs • Ensure the delivery of high quality and timely reports to project teams and clinical trial team

🎯 Anforderungen

• PhD in statistics strongly preferred; Candidates with MS in statistics, biostatistics or mathematics and a depth of relevant experience in drug development statistical research will be considered • A minimum of 8 years’ experience in progressive and relevant clinical trial experience • Experience with phase 3 study and regulatory submission is preferred • Experience leading teams and working in a matrix organization • Ability to communicate and work directly with non-statisticians imparting and delivering complex statistical information to scientific development partners and researchers • Excellent communication with an ability to present to a variety of stakeholders and tailor message accordingly • Experience managing CROs and other data vendors • Strong leader with a growth mindset, willing to learn from others, and dedicated to promoting a psychologically safe environment • Ability to keep pace in a fast-moving organization and navigate ambiguity • Advanced knowledge of statistical methods in clinical study designs (adaptive, Bayesian), statistical analysis methods including missing data imputation, multiplicity adjustment, estimand, Bayesian method, etc. • Knowledge and proficiency in SAS or R and other industry computational tools • Knowledge of CDISC standard including SDTM, ADaM • Knowledge of ICH guidelines, FDA / EMA / other regulatory authority guidance • Experience in planning, running and documenting simulations, including clinical trial simulations • Experience working in a remote virtual environment • Successfully exhibit 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 held twice per year, additional travel may be required to attend key Phase 3 meetings, typically held at the Apogee San Francisco office

🏖️ 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