About the Opportunity
We are currently partnered with a global biopharmaceutical company that is seeking Biostatisticians (Associate Director/Principal/Senior) to enhance their dynamic team in the Greater Philadelphia region. This client is dedicated to a noble mission – the discovery, development, and commercialization of groundbreaking medicines aimed at addressing profound unmet medical needs in the fields of oncology, inflammation, and autoimmunity. Apply today to join them on this remarkable journey toward innovative solutions in healthcare!
The annual base salary range is $160,000 to $180,000. Actual compensation offered to the successful candidate may vary from posted hiring range based upon geographic location, work experience, education, and/or skill level, among other things. Details about eligibility for bonus compensation (if applicable) will be finalized at the time of offer.
Job Responsibilities
- Serve as a member of the biometrics management team, to manage and support drug development
- Provide strategic input to drug development and the development of the biometrics department
- Manage and develop statisticians
- Provide statistical input to study protocols
- Write and review statistical analysis plans
- Provide guidance and supervision to statisticians and programmers in authoring of analysis dataset specifications and programming of tables, listings and figures
- Interpret study results and provide review of statistical summary reports of study results for accuracy
- Assist in writing relevant sections of the clinical study report
- Participate and contribute to authoring of Clinical Development Plan
- Participate in regulatory activities such as health authority meetings and submission related activities
- Participate in the development and enforcement of SOPs and guidelines
Job Requirements
- PhD in Biostatistics / Statistics / Applied Statisitics
- Minimum of 7-9+ years of pharmaceutical/biotechnology industry experience
- Experience in oncology drug development, from Phase I to Phase III
- Broad knowledge of biostatistics, FDA/EMEA guidelines, and the drug development process