Job Title: Principal Medical Affairs Biostatistician
Location: Remote (Cambridge, MA, US; Toronto, ON, CA)
Job Type: Full-time
Posted: Dec. 18, 2024
Job ID: 295
Job Overview:
As a Principal Medical Affairs Biostatistician at Cytel, you will contribute to post-approval study designs, the development of study protocols and analysis plans, and the interpretation of clinical trial and observational data. Your responsibilities will span across Medical Affairs, collaborating with multiple internal teams such as Medical Research, Regulatory, and Epidemiology to support statistical needs in post-approval clinical studies.
Responsibilities:
Collaborate with teams to design post-approval studies.
Write statistical sections of study protocols, consulting with internal and external experts.
Contribute to or prepare statistical analysis plans (SAPs).
Work closely with Data Management and Medical Research on the design of eCRFs.
Provide statistical guidance on the conduct of ongoing studies.
Oversee collaboration with Statistical Programming to implement statistical analysis of clinical trials, registries, observational, and non-interventional data.
Contribute to observational study reports and regulatory documents (e.g., DSURs, briefing documents).
Assist in preparing scientific articles summarizing data from studies.
Participate in meetings to support Biostatistics and Medical Affairs.
Qualifications:
Education: PhD in Biostatistics, Statistics, or a related field, with at least 3 years of pharmaceutical biostatistics experience; or an MS with at least 5 years of relevant experience.
Skills:
Excellent written and oral communication and presentation skills.
Extensive experience in programming with SAS.
Strong experience in data analysis with clinical studies databases.
Experience with post-approval observational and clinical studies.
Understanding of ICH GCP and industry practices and standards.
Proficiency in R programming and other statistical software.
Experience with CDISC (SDTM, ADaM, CDASH).
Additional Information:
Cytel is a global leader in statistical software and advanced analytics for clinical trials. They are known for their scientific rigor and operational excellence.
The company values diversity, innovation, and collaborative efforts to advance the state of clinical development.
This role offers the opportunity to contribute to impactful work in clinical trials while collaborating across various functions in the field of medical affairs.
Gujarat :
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Siliguri |Illinois :
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Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
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Tartu | Estonia |Harju County (Maakond) :
Tallinn |Hà Nội :
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