Sr. Director, Biostatistics

Ipsen

About The Position

The Senior Director, Biostatistics will be working in a cross functional team, responsible for providing program and project-level statistical expertise and leadership in the development of Ipsen oncology assets. This position reports to the Head of Biostatistics, based in the USA. The Senior Director will lead and mentor a team of biostatisticians, fostering a collaborative and innovative environment. This role is pivotal in advancing Ipsen's mission to improve patient outcomes through innovative treatments. The Senior Director will also engage with external stakeholders, including regulatory agencies and academic institutions, to ensure alignment with industry standards and scientific advancements. Ensuring data integrity and compliance with regulatory standards is a critical aspect of this role. The Senior Director will participate in the evaluation of prospective assets as part of the due diligence process, including initial assessments, pre-diligence, and full/confirmatory diligence. He/she will collaborate with other R&D functions in development of clinical development plans to inform the modelling of potential costs and revenue. The Senior Director is expected to have an in-depth understanding of advanced statistical methods, including innovative trial designs and endpoints, missing data, and multiplicity handling. She/he will have a thorough understanding and capability to implement state-of-the-art innovative statistical methodology for the design, conduct, and evaluation of clinical trials. In addition, she/he will have the capacity to understand relevant multi-disciplinary knowledge and interact effectively with within the biometrics department with clinicians, regulatory affairs, medical writing, clinical operations, service/technology providers, as well data management and statistical programming.

Requirements

10+ years of pharmaceutical industry experience with a PhD, or 12+ years with an MS, at least 5 years in a leadership role.
Advanced knowledge and practical experience of widely used clinical study designs as well as complex study designs.
Hands-on familiarity with common and advanced statistical methodology including methods adopted in adaptive design.
Expertise in applying, analyzing, reporting, and interpreting both descriptive and inferential statistics.
Strong knowledge of SAS programming concepts and techniques in the pharmaceutical, with the ability to proactively address strategic limitations; proficiency in tools such as SAS, R, EAST, nQuery, and JMP.
Hands-on experience working with CDISC standards and programming based on raw datasets, SDTM, and ADaM datasets.
Excellent communication skills, both written and verbal, with the ability to convey complex statistical concepts clearly across functional areas.
Strong attention to detail.
Proven ability to collaborate effectively in global, cross-functional, and culturally diverse teams; strong interpersonal and relationship-building skills.
Demonstrated initiative, flexibility, and independent problem-solving skills with a proactive, positive approach.
Strong project and time management skills.
Deep understanding of statistical methodologies, clinical study designs, and the drug development process.
Ability to see the big picture while maintaining attention to detail.
Ability to manage multiple complex projects and assess resource needs.
MS in statistics or biostatistics is required.
Fluent in English, with excellent verbal and written.

Nice To Haves

Oncology drug development experience is highly desired.
Regulatory submission (US FDA, EMA, PMDA) experience is highly desired.
PhD in statistics or biostatistics is strongly preferred.

Responsibilities

Work as program-level lead biostatistician in cross-functional team(s).
Responsible for providing strategic support to Ipsen asset team(s), as well as authoring and reviewing key study documents such as study protocol, statistical analysis plan, dataset specifications, clinical study report, publications, and regulatory submission documents.
Provide strategic leadership and direction within oncology programs, leveraging deep expertise to influence product and/or business strategy.
Lead and coordinate the planning and execution of biostatistics deliverables, ensuring quality and adherence to timeline, by collaborating with internal and CRO team members.
Make decisions guided by functional, divisional, and enterprise-level priorities, with a direct impact on business outcomes.
Ensure accuracy, precision, efficiency, and robustness in statistical planning, study design, and statistical analysis interpretation, reporting, and presentation of clinical study results.
Evaluate and interpret clinical trial data, prepare slides, and present results to internal and external stakeholders.
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.
Support the preparation and validation of statistical analyses for use in regulatory documents and scientific articles.
Support internal ad-hoc and exploratory analysis.
Play a critical role in shaping team development through ongoing training, mentorship and career development opportunities, and contribute to departmental strategy.
Lead or contribute to high-visibility, cross-functional initiatives of strategic importance, including long term digital and data strategy, refinement of external sourcing, and optimization of internal processes.