Senior Director, Statistical Innovation
PharmaBiotechCROClinical ResearchRegulatory AffairsQuality Assurancebiostatisticssaspythonemacroinform
Job description
Title: Senior Director, Statistical Innovation Company: Ipsen Biopharm Ltd 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 Senior Director, Statistical Innovation leads innovative methodology, advanced modelling, and data-driven decision support across Ipsen’s R&D portfolio, strengthening development strategy through design, simulation, and predictive analytics. The role leads a specialist team of 3 to 5 quantitative experts supporting innovative trial design, advanced modelling, digital twins, virtual controls, patient journey modelling, and data mining to improve development decisions, study efficiency, population selection, and portfolio value. Working closely with Clinical Development, Biostatistics, Statistical Programming, Translational Medicine, Biomarkers, Regulatory Affairs, Data Science, Business Development, Asset Teams, and Biometry Leadership, the role ensures innovative statistical approaches are scientifically rigorous, operationally feasible, and aligned with regulatory, clinical, and portfolio decision needs. The role builds a sustainable statistical innovation capability through high-value use cases, standards, reusable tools, external engagement, specialist talent development, and broader Biometry and asset-team upskilling. WHAT - Main Responsibilities & Technical Competencies • Lead Statistical Innovation within Biometry, accountable for strategy, priorities, quality, and capability building across a 3 to 5 person specialist team. • Provide strategic input to innovative trial designs, including adaptive, Bayesian, enrichment, external-control, master protocol, interim, simulation, and endpoint strategies. • Develop simulation frameworks to assess operating characteristics, optimize sample size, test decision rules, and support go/no-go decisions. • Lead advanced modelling across clinical development and evidence generation, including disease progression, dose/regimen, patient journeys, digital twins, virtual controls. • Drive data mining and predictive modelling to identify response predictors, heterogeneity, enrichment opportunities, prognostic factors, and patient subgroups. • Advise on external controls, digital twins, Bayesian borrowing, historical data, and RWE, addressing bias, confounding, estimands, data quality, regulatory acceptability, and interpretability. • Identify and implement emerging statistical and modelling approaches for high-impact Ipsen use cases. • Establish standards, reusable code, templates, documentation, QC expectations, and governance for innovation deliverables. • Lead and develop statisticians through prioritization, coaching, recruitment input, and succession planning. • Work with Biostatistics and Statistical Programming to ensure methods are feasible, robust, reproducible, and submission-ready. • Represent Biometry in governance, asset reviews, development planning, due diligence, and external scientific discussions. • Build external networks with academics, consortia, and industry groups to maintain methodological currency. • Communicate complex statistical and modelling outputs clearly to support senior decisions, development strategy, and portfolio prioritization. HOW - Behavioural Competencies Required Competency Competency Behavioural Markers Explanation of Choice 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 Owns innovation strategy, methodology quality, priorities, and decision-ready outputs. Develops/Coaches Talent • Able to identify and align career goals, and blend organizational objectives into a cohesive development plan for self and team • Able to coach • Provides structured, actionable, regular and directional feedback and acts as a coach to empower people to own their own growth/development • Prepares their own succession plans • Displays a radically human-centered mindset; puts people first; focuses on doing good • Demonstrates ability to build team effectiveness Leads a specialist team and builds broader Biometry and asset-team capability. Drive Vision and Strategy • Paints a compelling picture of the vision (future status quo) and strategy that motivates others to action Sets direction for innovation, modelling, digital twins, and analytics to increase PTRS and portfolio value. 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 Navigates complex scientific, regulatory, data, modelling, and operational decisions. 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 Turns complex quantitative concepts into clear recommendations for teams, leaders, and stakeholders. HOW - Knowledge & Experience Knowledge & Experience (essential): • 10+ years of pharmaceutical, biotechnology, CRO, acade
Stand out for this role
NoxPharm tailors your CV to this job description by aligning your experience with the role requirements and terminology. Built for pharma & life sciences.
Tailor my CV now — free to trySimilar Pharma jobs
Associate - Business Planning & Analysis - Surgical Finance
Alcon — Fort Worth, Texas
Support Engineering Manager -West2 CMS team
Agilent Technologies — 2 Locations
Senior Facility Engineer
Takeda — USA - IL - Round Lake - Drug Delivery
Medical Support Specialist - EMT - B
Takeda — USA - CO - Longmont
Plasma Center EMT-I
Takeda — USA - IN - Bloomington
Plasma Center EMT-P
Takeda — USA - IN - Bloomington