Thermo Fisher Scientific izstrādā un piegādā tehnoloģijas, laboratoriju produktus un farmācijas pakalpojumus, kas atbalsta zinātnisko pētniecību un veselības aprūpi. Uzņēmuma darbība aptver dzīvības zinātņu pētniecību, analītisko problēmu risināšanu, laboratoriju darba ražīgumu, diagnostiku, kā arī terapiju izstrādi un ražošanu. Uzņēmums apkalpo klientus ar globālas komandas un zīmolu portfeļa palīdzību, kurā ietilpst Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon un PPD. Uzņēmuma karjeras iespējas aptver zinātnes, veselības aprūpes, ražošanas, loģistikas un pakalpojumu darbības, kas nodrošina šos piedāvājumus.
Principal Biostatistician, Clinical Research
Lead statistical work across Thermo Fisher Scientific clinical research programs, from study design and protocol development through final analysis and reporting. Apply SAS, CDISC standards, and statistical methods to Phase I–III trials.
Apraksts
- Apply statistical expertise to support the development of life-changing therapies.
- Join the Clinical Research team in Thermo Fisher Scientific’s Functional Service Provider division.
- Partner with clients while drawing on the resources of an established clinical research organization.
- Carry out statistical work across all stages of the clinical trial process.
- Help shape study designs and write protocols.
- Complete final analyses and prepare reports.
- Support advanced clinical development programs and contribute to improved health outcomes.
Prasības
- Advanced degree and at least 6 years of clinical research biostatistics experience, or a bachelor’s degree and at least 8 years; experience with Phase I–III trials is emphasized.
- Preferred education in statistics, biostatistics, or a related quantitative discipline.
- Expert proficiency in SAS programming and statistical methods.
- Strong understanding of ICH-GCP guidance and clinical trial regulations.
- Experience developing and reviewing statistical analysis plans.
- Ability to oversee several clinical trials at the same time.
- Advanced understanding of CDISC standards and their application.
- Experience with statistical tools such as R, EAST, or WinBUGS.
- Strong analytical reasoning and problem-solving abilities.
- Excellent written and spoken communication skills.
- Ability to work effectively with regulatory agencies, including the FDA and EMA.
- CRO and vendor management experience is preferred.
- Familiarity with autoimmune or oncology therapeutic areas is beneficial.
- Ability to collaborate effectively with colleagues.
- Ability to meet deadlines while balancing competing priorities.
- Careful attention to detail and a strong focus on quality.
Priekšrocības
- Fully remote work arrangement.
- Standard Monday-to-Friday schedule.