Spyre Therapeutics — ішектің қабыну ауруына (ІҚА) арналған антиденеге негізделген емдеу әдістерін әзірлейтін биофармацевтикалық компания. Оның зерттеулері пациенттер үшін емнің тиімділігі мен қолайлылығын арттыруға бағытталған дәл иммунологияға, үздік антиденелерге және ұтымды емдеу комбинацияларына шоғырланады. Компания ІҚА-ны емдеудің жаңа нұсқаларын ілгерілету үшін ынтымақтастыққа негізделген тәсіл арқылы бірнеше ауру бойынша емдеу әдістерін әзірлеу және коммерцияландыру тәжірибесі бар мамандарды біріктіреді.
Senior Director of Biostatistics - Spyre Therapeutics, Hybrid United States
Lead biostatistics strategy for Spyre Therapeutics’ clinical-stage immunology programs. Oversee trial design, statistical analyses, regulatory support, and biometrics vendor operations.
Америка Құрама Штаттары295 000 $ – 314 000 $ / жыл
АраласТолық жұмыс күніАға маманҚажетті Тіл: ағылшын тіліДиректорСипаттама
- Provide strategic biostatistical leadership for assigned clinical development programs
- Lead program-level biometrics teams comprising statisticians, data managers, and statistical programmers
- Support trial design, protocol development, sample-size calculations, CRF development, results interpretation, clinical study reports, and regulatory responses
- Evaluate advanced statistical methods that may improve clinical study success
- Develop statistical analysis plans and specifications for derived variables, tables, figures, and listings
- Advise study teams on statistical activities and partner with data managers to maintain data quality
- Collaborate with clinical, operational, data management, safety, regulatory, project management, translational medicine, and vendor teams
- Establish CRO and vendor oversight processes to support accurate, timely deliverables
- Support global Health Authority submissions and participate in related meetings and teleconferences
- Coordinate statistical analyses for investigator brochures, DSUR updates, periodic safety updates, and ad hoc requests
- Oversee biometrics vendors producing analysis files, statistical analyses, results, and data deliverables
- Complete additional duties as assigned
Талаптар
- PhD in Biostatistics, Statistics, or a related discipline
- 10–12 years of biostatistics experience in pharmaceutical, biotechnology, or CRO settings
- Strong command of statistical methods and their use in clinical trials and health research
- Working knowledge of Bayesian methods preferred
- Experience supporting regulatory submissions and agency interactions
- Proficiency with statistical tools including SAS and R, along with data management systems
- Experience applying CDISC standards, including SDTM, ADaM, and CDASH
- Demonstrated ability to work independently in a matrixed organization and address emerging issues
- Excellent communication, interpersonal, and organizational capabilities
- Ability to collaborate effectively within multidisciplinary teams
Артықшылықтар
- Competitive compensation and benefits package
- Performance-based bonus
- Equity grant opportunities
- Health, welfare, and retirement benefits
- Unlimited paid time off
- Two company-wide shutdowns of one week each year
- Professional development opportunities
- Remote work setting with frequent in-person meetings
- Opportunity to contribute in a fast-moving environment and help shape a growing company