Principal / Associate Director Biostatistician
|Date Posted||January 18, 2023|
|Job Status||Not Specified|
Principal/Associate Director Biostatistician 1310433
Location: Cambridge MA (Remote)
Therapeutics Areas: Oncology
Job Overview: The incumbent will be involved in the design, execution, analysis and reporting of clinical studies as well as gain experience in regulatory interactions.
Serve as the biostatistics leader and point-of-contact in multiple clinical development teams responsible for determining clinical study strategies and delivering results with high quality and on time.
Leader in bringing innovative statistical thinking and methods to help drive applications of suit-for-purpose statistical methods that enhance the probability of successes for clinical development programs.
Collaborate with internal and external stakeholders to ensure effective quantitative approaches are applied to the collection and analysis of a wide variety of data types.
Participates in activities and meetings to support Biostatistics and the Development Team as needed
Develop statistical sections of clinical development plans, protocols, statistical analysis plans, and key specifications for statistical programming implementation of analyses.
PhD degree with 5+ (or master’s degree with 8+ years) of relevant work experience in Biotech, Pharma, Regulatory agencies, or Clinical Research Organizations.
Excellent statistical knowledge with the ability of applying the knowledge to solve scientific and clinical problems.
Working knowledge of relevant FDA, EMA, ICH guidelines and regulations.
Experience working with CROs, vendors, and relationship management preferred.
Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.
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Cambridge, MA, US
Scientific and Clinical
November 15, 2022
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