Associate Director, Biostatistics

Title:

Associate Director, Biostatistics

Company:

Ipsen Innovation (SAS)

 

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:

WHAT - Summary & Purpose of the Position

The Associate Director of Biostatistics provides statistical insights across clinical trials, serving as the subject matter expert in study design, planning, and analysis. This role guides key activities including protocol development, sample size estimation, statistical analysis planning, and in-trial data reviews. It also oversees data quality, supports the generation of tables, listings, and figures, and ensures compliance with CDISC standards and regulatory requirements.

In addition to collaborate closely with internal and CRO partner members, the Associate Director plays a pivotal role in preparing statistical components of regulatory submissions. Operating independently, this position ensures statistical rigor and collaborates cross-functionally to support sound clinical and regulatory decision-making.

WHAT - Main Responsibilities & Technical Competencies

• Serve as the lead biostatistician at the study level, authoring and reviewing key documents including protocols, statistical analysis plans, dataset specifications, clinical study reports, publications, and regulatory submissions.
• Collaborate cross-functionally and with CRO partners to plan and execute biostatistics deliverables with high quality and within timelines.
• Provide oversight and guidance to CROs, ensuring a clear understanding of clinical data and statistical methodologies; validate and QC their work to ensure accuracy.
• Support regulatory submissions and scientific publications through preparation and validation of statistical analyses. Support internal ad-hoc and exploratory analysis.
• Represent Biostatistics in regulatory interactions, including briefing document preparation and participation in meetings.
• Contribute to the development and refinement of departmental standards, processes, and best practices.
• Stay current with regulatory guidance, industry trends, and methodological innovations in biostatistics.

HOW - Behavioural Competencies Required

Manage Complexity (6)

• Identifies contradictory information/demands/inputs to effectively solve problems
• Develops and evaluates alternative scenario and solutions
• Able to identify what truly matters and ruthlessly focus/ prioritize on making decisions with real impact

This role requires navigating complex clinical data, regulatory standards, and statistical methodologies. The ability to manage and simplify complexity is essential for sound decision-making and strategic planning.

Ensures Accountability (26)

• Ensures single accountable referents per task/project/outcome (independent of organizational context or multi-team projects)
• Builds and anchors an environment where people have the skills and habits to ask for clarification when accountabilities are unclear
• Consults/seeks relevant stakeholder views/expertise and coaches/ensures decisions are made by consent vs. consensus
• Takes personal accountability for decisions, actions, successes and failures, and fosters the same for others
• Follows through on commitment and makes sure others do the same

The role involves oversight of CROs, regulatory submissions, and internal teams. Accountability is critical to ensure quality, compliance, and timely delivery of statistical outputs.

Communicates Effectively (22)

• Asks open questions and digs deeper; shows care and respect for different perspectives (both verbally and non-verbally) and able to relate to other points of view
• Communicates transparently, "tells it how it is" while keeping the communication respectful
• Builds clear and crisp messages with structure and focus, uses visual communication and storytelling to make the message easy to digest and connect with the outcomes
• Demonstrates gravitas

Clear communication is essential for cross-functional collaboration, regulatory interactions, and documentation. This competency ensures clarity, precision, and influence in high-stakes environments.

Influences (20)

• Listens and observes actively (paraphrases, summarizes, uses body language) and reflects on what was said, builds on what others are saying
• Gets insights on objectives of other stakeholders and is able to identify common interests
• Actively seeks "win-win" partnerships/solutions
• Able to embark internal and/or external stakeholders without hierarchical relationships

The Associate Director must influence internal teams, external partners, and regulatory bodies. This competency supports building consensus and driving alignment across diverse stakeholders.

Excellence in Execution (25)

• Approaches priority setting and setting the stage through the lens of execution
• Establishes clarity about the goals, accountabilities, timelines, and next steps; can identify/spot opportunities for real impact on patient and society
• Able to be focused and performance-driven with clear KPIs
• Plans and aligns effectively (steps, resources, timelines etc.)
• Displays a commitment to best practice sharing and setting
• Promotes single point of accountabilities

Precision and timeliness are vital in clinical trials and regulatory submissions. This competency ensures the role delivers high-quality outputs aligned with organizational goals.

HOW - Knowledge & Experience

Knowledge & Experience (essential):

• Minimum of 8+ years of relevant clinical biostatistics experience in the pharmaceutical, biotech, or medical device industry with a Master’s degree, or 6+ years with a Ph.D. (or equivalent).
• Proven experience in clinical development and regulatory submissions.
• Demonstrated ability to implement state-of-the-art statistical approaches in the design, execution, and evaluation of clinical trials.
• Demonstrated expertise in advanced statistical methods, including innovative trial designs, endpoint strategies, survival analysis, and approaches for handling missing data and multiplicity.
• Expertise in SAS and R programming for data management, analysis, visualization, and generation of clinical trial outputs.
• Strong command of statistical and data management principles applied to clinical research, with a solid understanding of regulatory standards (e.g., GCP, ICH, CDISC).
• Excellent strategic-thinking and problem-solving skills, with the ability to proactively identify and address complex issues.
• Effective communicator with strong verbal, written, and presentation skills; able to influence and engage senior stakeholders across functions and geographies.
• Demonstrated success in stakeholder management, negotiation, and guiding teams through complex decision-making scenarios.
• Strong project and time management skills, with the ability to lead multiple complex projects and assess resource needs.
• Self-directed and resourceful, with the ability to evaluate alternatives, take initiative, and communicate recommendations clearly.
• Proficient in MS Word, Excel, and PowerPoint.
• Ability to represent biostatistics in discussions with clinical and regulatory key opinion leaders, including advisory boards and expert consultations.
• Skilled in making sound, well-supported decisions in ambiguous or high-impact situations.
• Strong interdisciplinary knowledge with the ability to collaborate effectively across biometrics, clinical operations, medical writing, regulatory affairs, IT, and external partners to drive strategic alignment and execution.

Education / Certifications (essential):

•  Master’s degree required.

Education / Certifications (preferred):

•  Ph.D. (or equivalent degree) is strongly preferred.

Language(s) (essential):

• Fluent in English is required.

Language(s) (preferred):

• French is a plus.

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.

The annual base salary range for this position is $143,250-$210,100.

This job is eligible to participate in our short-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.

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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.