Impress employers and recruiters.
Choose from hundreds of resume examples.

Target Resume Now

Tailor your resume to this Senior Director, Biostatistics Rare Diseases role.

Rezi rewrites your resume against Ipsen's job description. Free.

Resume score gauge reading 58 out of 100

Don't guess if your resume is good enough.

See how it scores against the Senior Director, Biostatistics Rare Diseases posting at Ipsen — free, in seconds.

About the Role

The Senior Director, Biostatistics will provide statistical expertise and leadership for the development of rare disease assets within a cross-functional team. This pivotal role involves leading and mentoring a team, engaging with external stakeholders, and ensuring data integrity and regulatory compliance.

Responsibilities

Serve as program-level lead biostatistician in cross-functional teams.
Provide strategic support to Ipsen asset teams.
Author and review key study documents including protocol, statistical analysis plan, dataset specifications, clinical study report, publications, and regulatory submission documents.
Provide strategic leadership and direction within rare disease programs.
Influence product and/or business strategy through deep expertise.
Lead and coordinate the planning and execution of biostatistics deliverables.
Ensure quality and adherence to timelines by collaborating with internal and CRO team members.
Make decisions guided by functional, divisional, and enterprise-level priorities.
Ensure accuracy, precision, efficiency, and robustness in statistical planning, study design, and 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 CRO partners.
Validate and QC CRO work to ensure quality and accuracy of statistical deliverables.
Support the preparation and validation of statistical analyses for regulatory documents and scientific articles.
Support internal ad-hoc and exploratory analysis.
Shape team development through training, mentorship, and career development opportunities.
Contribute to departmental strategy.
Lead or contribute to high-visibility, cross-functional initiatives of strategic importance.
Participate in the evaluation of prospective assets as part of the due diligence process.
Collaborate with other R&D functions in the development of clinical development plans.

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 and complex clinical 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 industry.
Ability to proactively address strategic limitations.
Hands-on experience working with CDISC standards and programming based on raw datasets, SDTM, and ADaM datasets.
Excellent communication skills, both written and verbal.
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.
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.
Rare disease drug development experience is highly desired.
Regulatory submission (US FDA, EMA, PMDA) experience is highly desired.

Skills

SAS programming
R
EAST
nQuery
JMP
CDISC standards
SDTM
ADaM datasets
Statistical methodology
Clinical study designs
Drug development process
Advanced statistical methods
Innovative trial designs
Missing data handling
Multiplicity handling
State-of-the-art innovative statistical methodology
Cross-functional collaboration
Project management
Time management
Problem-solving

Location

Work Type

Full-time

Experience Level

Senior
Director

Education Level

MS in statistics or biostatistics required
PhD in statistics or biostatistics strongly preferred

About the Company

Ipsen is a mid-sized global biopharmaceutical company focused on transformative medicines in 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.
Tackles areas of high unmet medical need through research and innovation.
Passionate teams in over 40 countries focused on bringing medicines to patients in 88 countries.
Builds a workplace that champions human-centric leadership and fosters a culture of collaboration, excellence and impact.
Empowers individuals to be their true selves, grow and thrive alongside the company’s success.
Journey towards sustainable growth, creating real impact on patients and society.

Equal Opportunity

Committed to creating a workplace where everyone feels heard, valued, and supported.
Embraces diversity and inclusion.
Values different perspectives and experiences.
Believes diverse ways of thinking lead to more thoughtful decisions and innovative solutions.
Strives to better understand the communities served.
Provides adjustments or support during the application process upon request.
Ipsen is an equal opportunity employer that strictly prohibits unlawful discrimination.
Recruits, employs, trains, compensates, and promotes without regard to 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.