Principal Statistician

Title:

Principal Statistician

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:

Job Title:  

Principal Statistician

Division / Function: 

R&D / Global Biometry / Biostats & Programming

Manager’s Job Title: 

Director, Biostatistics

Ipsen Job Profile:

Clinical Science > Biostatistics

Location:

Paris, FR/Paddington, UK

WHAT - Summary & Purpose of the Position

The Principal Statistician is the lead for the statistical strategy of one or more projects/studies in Ipsen development portfolio. He/She is responsible for the discussion and implementation of rigorous, informative and when appropriate, innovative study designs, statistical models, and analysis methodologies that optimally address the research objectives by establishing the efficacy and safety of the compound. He/She is responsible for designing, implementing and reporting in a quality, timely and accurate manner, the statistical processes in clinical trials, applying state of the art concepts and tools to the interpretation of clinical trial data so that the evaluation of such data will withstand interrogation and examination by Regulatory bodies. He/She oversees external vendors for outsourced activities and is responsible for the corresponding deliverables (quality, budget and timelines). He/She helps to introduce and develop patterns of work within the clinical research group to support and enhance the delivery of clinical development objectives and achievement of clinical excellence by encouraging a team-based approach.

WHAT - Main Responsibilities & Technical Competencies

Main Responsibilities:

• Take responsibility as a statistical adviser to global project teams and clinical study teams for appropriate project development and make contributions to the statistical work for other projects as required.
• Ensure that, in conjunction with the Early/Medical Development Director, and other groups (e.g. Pharmacokinetics) clinical development plans have a high quality, timely and robust statistical input.
• Ensure that clinical study protocols are developed with statistical input as early as possible, and that statistical review and approval of other relevant study documents (e.g. Data handling plan, Randomisation plan, SAP and TLF Shell, Clinical Study report), is conducted to high quality, robust, rigorous, objective standards.
• Lead project and study level activities with support from external vendors’ statisticians.
• Provide statistical input for selection and evaluation of external vendors and take responsibility for ensuring that the Service Provider statistical deliverables meet project specifications, and that they are produced to defined quality, content and timetable standards, and to liaise with the Purchasing Manager, to facilitate the achievement of timely, relevant, robust contracts and schedules of works.
• Ensure that the Clinical Development Department has the functional specifications, quality standards and statistical input to the Service Provider evaluation and management process in a time frame and in accordance with clinical study team outsourcing strategy.
• Co-ordinate the clinical research components of regulatory activities with respect to statistical methods, results and evaluation in such a way as to eliminate the chances of unsuccessful regulatory submissions. Provide the written and verbal elements of regulatory submissions around the world.
• Plan, schedule and track all statistical activities, to ensure high quality, timely and accurate completion of statistical deliverables.
• Present statistical methods used in clinical studies to Regulatory bodies when required: this includes the FDA and EMA as well as national bodies as appropriate.
• Manage the Statistical input to the regulatory review process, addressing Regulatory Bodies questions in a timely technically sound and clearly presented manner.
• Work closely with Data Management staff, within the Ipsen Group to ensure the timely availability of integrated quality databases to support ISS and ISE and the regulatory review process.
• Be responsible in conjunction with other Statisticians for increasing the awareness of clinical research staff in R&D groups in all Ipsen companies, of the importance of maintaining statistical rigor in the clinical research processes.
• Develop Statistical processes within the Ipsen Group by working with other statistician colleagues (i.e. Modelling and Simulation).
• Develop, implement or advise on appropriate new statistical developments by keeping abreast of current issues and developments in statistical theory and application.
• Maintain a good network of contacts with outside bodies relevant to clinical statistics, both within the EU and North America.
• Complete all the above activities within the framework and in compliance with R&D SOPs and other documentation in force within the Ipsen Group.

EHS responsibilities

• Comply with applicable EHS regulations and procedures.
• Participate in the site's EHS performance by reporting risks, malfunctions or improvements
• Participate in mandatory EHS training

HOW - Behavioural Competencies Required

Ensures Accountability

• 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

This role requires strong ownership of statistical deliverables, regulatory submissions, and oversight of CROs. Accountability is essential for ensuring data integrity and compliance.

Manage Complexity

• 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

The role involves navigating complex data, regulatory requirements, and cross-functional collaboration. Managing complexity is key to effective decision-making.

Communicates Effectively

• 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

Effective communication is vital for regulatory interactions, cross-functional leadership, and scientific publications.

HOW - Knowledge & Experience

Knowledge & Experience (essential):

• Approximately 3-6 years’ experience in a similar position
• Advanced knowledge of Statistics and the drug development process applied to clinical studies
• High knowledge of international standards (ICH, GCP, CDISC …) and regulatory submission experience (FDA, EMA, etc.)
• Proficiency with statistical software tools such as SAS, R, S-Plus, EAST, JMPC, etc.
• High level of expertise of oversight and management of external vendors
• Ability to manage projects/study: plan activities and tasks, identify project constraints and dependencies, identify and mitigate risks, report on project status, produce progress metrics and communicate efficiently with external vendors as well as internal partners
• Ability to produce high quality, accurate work to meet deadlines
• Ability to interact satisfactorily with staff of differing disciplines
• Well-developed time management, communication, presentation, analytical and interpersonal skills

Knowledge & Experience (preferred):

•  Approximately 2-4 years’ experience as statistician in clinical research

Education / Certifications (essential):

•  MS in statistics or biostatistics is required

Education / Certifications (preferred):

• PhD in statistics or biostatistics is prefered

Language(s) (essential):

•  Fluent in English (verbal and written)

#LI-MM1 #LI-hybrid

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