Senior Director, Biostatistics - Rare Diseases

Title:

Senior Director, Biostatistics Rare Diseases

Company:

Ipsen Biopharmaceuticals Inc.

About Ipsen:

Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Supported by nearly 100 years of development experience, with global hubs in the U.S., France and the U.K, we tackle areas of high unmet medical need through research and innovation.

 Our passionate teams in more than 40 countries are focused on what matters and endeavor every day to bring medicines to patients in 88 countries. We build a workplace that champions human-centric leadership and fosters a culture of collaboration, excellence and impact. At Ipsen, every individual is empowered to be their true selves, grow and thrive alongside the company’s success. Join us on our journey towards sustainable growth, creating real impact on patients and society!

For more information, visit us at https://www.ipsen.com/ and follow our latest news on LinkedIn and Instagram.

Job Description:

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 rare disease 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.

WHAT - Main Responsibilities & Technical Competencies

• 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 rare disease 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.

HOW - Knowledge & Experience

Knowledge & Experience (essential):

• 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.

Knowledge & Experience (preferred):

• Rare disease drug development experience is highly desired.          
• Regulatory submission (US FDA, EMA, PMDA) experience is highly desired.

Education / Certifications (essential):

• MS in statistics or biostatistics is required.

Education / Certifications (preferred):

• PhD in statistics or biostatistics is strongly preferred.

Language(s) (essential):

• Fluent in English, with excellent verbal and written

Ipsen Biopharmaceuticals, Inc. is an equal opportunity employer. We recruit, employ, train, compensate, and promote without regard to race, religion, creed, national origin, age, gender, sexual orientation, sexual identity, marital status, military or veteran status, disability, genetic information, or any other category protected by applicable federal, state or local law.

Ipsen Biopharmaceuticals, Inc. conducts background screening, reference checks, and drug testing as part of its pre-employment screening process. This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time.  The employee may be requested to perform different or additional duties as assigned.

All Employees are expected to adhere to all company policies and act as a role model for company values.

For candidates based in the United States, the annual base salary range for this position is $270,000 to $330,000. This job is eligible to participate in our short-term incentives program as well as our long-term incentives program.

At Ipsen we are proud to offer a comprehensive employee benefits package, including 401(k) with company contributions, group medical, dental and vision coverage, life and disability insurance, short- and long-term disability insurance, as well as flexible spending accounts. Ipsen also provides parental leave, paid time off, a discretionary winter shutdown, well-being allowance, commuter benefits, and much more.

The pay range displayed above is the range of base pay compensation within which Ipsen expects to pay for this role at the time of this posting. Individual compensation within this range depends on a variety of factors, including, but not limited to, prior education and experience, job-related knowledge and demonstrated skills.

We are committed to creating a workplace where everyone feels heard, valued, and supported; where we embrace “The Real Us”. The value we place on different perspectives and experiences drives our commitment to inclusion and equal opportunities. When we include diverse ways of thinking, we make more thoughtful decisions and discover more innovative solutions. Together we strive to better understand the communities we serve. This means we also want to help you perform at your best when applying for a role with us. If you require any adjustments or support during the application process, please let the recruitment team know. This information will be handled with care and will not affect the outcome of your application. 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.