Director Biostatistics Due Diligence

Cambridge, MA, United States
Jan 01, 2021
Required Education
Position Type
Full time
Director Biostatistics Due Diligence

Ipsen Bioscience, Inc.

Job Description:

Are you looking for an opportunity to apply your biostatistics subject matter expertise in due diligence and assessment activities?

As Director Biostatistics, you will lead biostatistical evaluations on all Due Diligences, bringing statistical expertise to the assessment of an asset from early to late stage clinical development and provide well supported opinion and recommendations related to the biostats evaluation to enable informed and data driven decisions within the Business Development team. You will serve as the nominated independent biostatistical member of various internal committees and as the primary back up to the Head of Biostats and Programming on governance Committees. Additionally, you will act as an internal Biostatistical Expert to all Therapy Area Biostats teams, bringing to study/project teams mentoring, training and guidance on advanced statistical methodologies and support all Therapy Area statistical leads preparing for regulatory bodies and serves as back up expert at briefing meetings when required.

Your role will involve:

Due Diligence:
  • Primary Point of Contact and hands on biostats expert supporting all due diligence assessment teams. Performs a range of statistical assessments for the assets under review (from Pre-Clinical to late stage Clinical Development).
  • Manages own work to schedule/quality and applies a range of Statistical methods. Able to solve complex problems with minimal support needed and participates in multi-disciplinary teams providing strategic evaluation of assets in review.
  • Ensures efficient and effective coordination of Therapy Areas Biostats input within the timelines required. Contributes to strategy discussions from a biostatistical point of view on assets and programs. Engages with Head of Biostats and Programming on complex assessments to ensure alignment from biostats perspective to enable data driven decisions within BD team.

Internal Biostats Expertise:
  • Serves as primary or back up biostatistical member on various internal committees: Including but not limited to Protocol Assessment Committee (PAC), Program Steering Committee (PSC)
  • Serves as internal biostats expert providing advice and support to the Therapy Area statistical teams as needed. Specifically supports education and input needs on complex clinical study designs to ensure biostatistical sections within protocols, SAP etc are well thought through, clearly written and fit for purpose.
  • Supports appropriate biostatistical input into documents to be provided to Regulatory Authorities ( e.g., Briefing Books, submission dossier…etc).
  • Contributes as needed to presentations in front of regulators
  • Contributes to educational needs and mentoring across biostatistical teams within R&D as well as Global Medical Affairs to ensure consistency of processes and quality of output of the biostats deliverables.
  • Identifies opportunities to improve the methodology and provides practical solutions to study teams

In return, you will bring:
  • Advanced degree (PhD level preferred) in biostatistics, statistics, or related field
  • Minimum of 10 years of progressively responsible statistical experience in a pharmaceutical, biotechnology, contract research organization (CRO) or related business.
  • Expert on drug development processes and regulatory requirements, including ICH/GCP guidelines
  • Demonstrated understanding and significant working knowledge of statistical theory and its application in the pharmaceutical/biotechnology industry, including complex statistical methodologies, e.g. group sequential design, Bayesian methods, multiple imputation, etc.
  • Expert on the conduct of statistical analyses, using SAS and R statistical software.
  • Hands-on experience supporting clinical studies, working with clinical teams and interacting with regulatory agencies. Prior BLA, NDA and/or MAA experience is highly desirable
  • Expert communicator, adept at explaining complex topics to stakeholders with a variety of non-technical backgrounds. Superior technical writing skills.
  • Ability to influence without direct authority, working independently and collaboratively, in a fast-paced, matrixed, team environment consisting of internal and external members
  • Excellent understanding of clinical development and regulatory approval process (EMA and FDA), GCP, statistical software and processes used within the global biotech /pharmaceutical industry
  • Significant experience of working on regulatory submissions to various authorities, especially the FDA and EMA
  • Good knowledge of early phase activities -up to Proof of Concept.
  • Good understanding of Data Management and programming requirements, processes and principles
  • Experience with CDISC datasets, including ADaM and SDTM
  • Ability to present complex concepts and information related to statistical activities and requirements in a clear, logical and non-technical manner to various audiences at all levels within the organization

If this sounds like an exciting opportunity in to provide your expertise to support all due diligence assessment teams globally, 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.","datePosted":"2020-12-21T00:00:00.000Z