Principal Biostatistician, Rare Disease

Location
Cambridge, MA, United States
Posted
Feb 12, 2021
Ref
R-06800
Hotbed
Genetown
Required Education
Doctorate/PHD/MD
Position Type
Full time
Title:
Principal Biostatistician, Rare Disease

Company:
Ipsen Bioscience, Inc.

Job Description:

Are you looking for an opportunity to apply your knowledge of statistics and the drug development process on a global rare disease team?

As the Principal statistician you will be responsible for providing study level statistical expertise and leadership in the development of Ipsen's key Rare Disease assets. You will report to the Biostatistics Lead for the Rare Disease Therapeutic Area, based in the USA.

Your role will involve:
  • Work as study level lead biostatistician in a cross-functional team. Responsible for authoring and reviewing key study documents such as study protocol, statistical analysis plan, dataset specifications, clinical study report, publications, and regulatory submission documents.
  • Serve as a key contributor in project planning. Work collaboratively with internal and CRO team members to coordinate the planning and execution of biostatistics deliverables with quality and within timeline.
  • Provide oversight and guidance to ensure CRO partner understands the nature of the clinical data being collected and the approaches to summarizing the information. Validate and QC CRO's work to ensure the quality and accuracy of the statistical deliverables.
  • Help prepare and validate analyses for use in regulatory documents and scientific articles. Support internal ad-hoc and exploratory analysis


In return, you will bring:
  • PhD in statistics or biostatistics with at least 3 years of experience in pharmaceutical industry or MS with at least 6 years of pharmaceutical industry experience.
  • Advanced knowledge and practical experience of widely used clinical study design as well as complex study designs. Hands-on familiarity with common and advanced statistical methodology including methods adopted in survival analysis. Expertise in applying, analyzing, reporting and the interpretation of both descriptive and inferential statistics.
  • Proficiency with statistical software tools such as SAS, S-Plus, R, EAST, JMPC, etc. Hands on experience working in CDISC environment and programming based on raw datasets, SDTM, and/or ADaM datasets.
  • Excellent oral and written communications skills.
  • Strong collaborative skills and ability to work with a global cross-functional team.
  • Strong project and time management skills.
  • Previous experience working on Rare Disease studies in a pharmaceutical setting is highly desired.
  • Regulatory submission (FDA and EMA) experience is highly desired.


If this sounds like an exciting opportunity in rare disease clinical development to apply your ability to see the big picture, while keeping an eye on the detail, apply today!

IPSEN is an equal opportunity employer that strictly prohibits unlawful discrimination. We recruit, employ, train, compensate, and promote without regard to an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.