Director of Biostatistics, Oncology

Location
Cambridge, MA, United States
Posted
Jul 28, 2021
Ref
R-08306
Hotbed
Genetown
Required Education
Bachelors Degree
Position Type
Full time
Title:
Director of Biostatistics, Oncology

Company:
Ipsen Bioscience, Inc.

Job Description:

Are you a biostatistician looking for an opportunity to lead oncology projects?

As Director of Biostatistics you will be the biostatistics lead for one or more assets in the Ipsen oncology development portfolio. You will be actively involved in all statistical design, conduct and analysis of rigorous, informative, and innovative development programs, applying appropriate methodologies that optimally establish the efficacy, safety and value of the compound as guided by the target product profile. As Director you will be the main point of contact and subject matter expert for the Oncology Asset team(s), the protocol design teams, the study / clinical operations teams and within Biostatistics and Statistical programming for all oncology projects and will provide input into briefing books and participate in submissions including but not limited to acting as the biostatical representative at health authority meetings and supporting responses to HA questions and requests. Additionally, as Director, you will manage internal resources, lead external vendors assigned to support oncology clinical programs and liaise with other colleagues within Biostatistics and Statistical Programming for additional support needed. The Director is responsible for the quality of all biostatical deliverables, management of assigned budget and agreed timelines for all assigned projects.

Your role will involve:
  • Serving as biostatistics subject matter expert to asset teams and clinical sub-teams for oncology projects.
  • Ensuring that, in conjunction with Early Development (REED function) and Development Medical Directors, and other groups (e.g. Pharmacokinetics), clinical development plans have a high quality, timely and robust statistical input.
  • Ensuring that clinical study protocols are developed with statistical input and guidance as early in concept stage as possible, and that statistical review and approval of other relevant study documents is conducted in compliance with all governing policy and procedures and to high quality, robust, rigorous, objective standards.
  • Acting as Biostatistical Lead on project and study level activities, with support from internal/external resources and external vendors' statisticians as appropriate.
  • Supporting selection and evaluation of any external providers needed outside of the designated Strategic Partners, in compliance with governing procurement policy and procedures.
  • Coordinating the clinical research components of regulatory activities with respect to statistical methods, results and evaluation in such a way as to eliminate the chances of unsuccessful regulatory submissions. Providing the written and verbal elements of regulatory submissions around the world.
  • Presenting statistical methods used in clinical studies to Regulatory bodies when required, including US FDA, EMA, and PMDA.
  • Managing the statistical input to the regulatory review process, addressing regulators' questions rigorously and efficiently.
  • Developing, implementing or advising on appropriate new statistical developments by keeping abreast of current issues and developments in statistical theory and application.
  • Planning, scheduling and tracking all statistical activities, to ensure high quality, timely and accurate completion of statistical deliverables
  • Completing all the above activities in compliance with Ipsen R&D SOPs and practices.
  • Completing any other activity which may be reasonably required from time to time (for example: process improvement initiatives, SOP review/updates, training needs within R&D on statistical areas to improve internal knowledge and capabilities)


In return, you will bring:

Education / Certifications:

PhD in Statistics, Biostatistics, or related discipline highly desirable: honors degree in relevant subject with required experience will be considered

Experience :
  • >12 years of experience as a biostatistician working on oncology clinical studies.
  • Substantial NDA/MAA experience and extensive interactions with Health Authorities. Extensive experience in selection and management of external vendors.
  • Expert understanding of clinical development of oncology therapeutics.
  • Substantial experience with adaptive designs and innovative methodologies


Languages :

Proficient in verbal and written English

To learn more about this opportunity, 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.