Head of Statistical Consulting, Principal Statistician (UK/Netherlands based)

The Company Scendea is an international product development and regulatory consulting group delivering market-leading scientific expertise & regulatory solutions, to advance healthcare innovation worldwide. We are passionate about delivering strategic and operational support to clients, with a strong commitment to problem-solving and redefining customer service. Our aim is to streamline the product development process, reduce time-to-market, and minimise overall development costs. With a current team of over 50 staff based in the UK, Netherlands, Australia, and the US, Scendea is undergoing a period of significant growth. The addition of new office locations and service lines is facilitating the delivery of expert global regulatory consulting services to our rapidly growing client base. The Role This is an exciting time to join Scendea as we enter the next phase of growth. Biostatistics plays a critical role in supporting objective, data-led decision-making within the regulatory space and Scendea are seeking a dynamic Head of Statistical Consulting, Principal Statistician with experience working in a regulatory consultancy and clinical environment. This role involves building and growing a new statistical consultancy division as a service line extension to our current offering. As an influential statistical leader, you will be directly responsible for shaping and delivering biostatistical strategies across both discovery and clinical development. You will be a pivotal member of the Scendea team responsible for providing and leading the statistical consultancy support for clients’ programs moving into clinical development and ensuring the use of optimised clinical design methodologies to drive robust evaluation of target engagement, and proof of mechanism. Our ideal candidate is someone with excellent communication skills, with a passion for the implementation of cutting-edge biostatistics, and clinical trial methodologies to support and drive effective quantitative decision-making for complex biological questions across diverse therapeutic indications. Ideally, they will have experience working within a fast-paced consultancy and have the novel data expertise required for strategic planning and decision-making, with extensive experience interacting with the FDA, MHRA and EMA. Key Objectives Provide support, and work closely with, Scendea’s operations team in all aspects of statistical consultancy. Apply statistical principles and leadership skills to influence early discovery R&D strategies to help our clients make objective, data-led decisions. Provide scientifically rigorous statistical consultancy, input and advice into clinical development plans, clinical trial protocols and synopsis’ (including definition of novel endpoints), sample size calculations, interpretation and review of statistical results and statistical analysis plans (SAP’s), clinical study reports (CSR), Investigator brochures and scientific manuscripts. Advise on best randomisation schemes/methodology to use for blinding and randomisation. Lead and contribute to the development and implementation of statistical strategies bridging from discovery to early and late-stage clinical development programmes across client portfolios and be able to identify and communicate statistical issues across multidisciplinary teams. Lead in a range of statistical methodologies with practical applications and communicate complex statistical concepts to key external and internal stakeholders, including defining and discussing novel/complex statistical methods and approaches. Support clients with statistical consultancy support, contribute to regulatory submissions by providing input into briefing books, presentations, and any other documentation at regulatory agency meetings and submissions, in particular with the FDA, EMA, MHRA. Lead the implementation of innovative statistical thinking and methods to help drive the enhanced drug development approaches/pathways. Act as the primary point of contact to manage Statistical Freelance Consultants including contracts, budgets, and quality oversight, as required. Develop and maintain expert-level awareness in the field of statistics by reading related literature and attending training classes, professional meetings, and statistical conferences. Provide appropriate and competitive budgets and timelines for statistical activities to support business development preparing/input into statistical budgets/proposals and attending BD/project and client meetings. Develop and implement statistical processes, SOP’s, Working Practises, and templates to ensure good scientific practices are followed and standards met. Create and deliver appropriate training tools for key internal stakeholders. Support Scendea’s Marketing activities including white papers, scientific papers, company brochure content, and marketing campaigns. Be instrumental in the future growth plans, recruitment, and day-to-day management. Location & Reporting Structure The role will be a full-time, hybrid position, candidates must be based in either the UK or The Netherlands. The selected candidate will report to the Director. Skills and Experience MSc or PhD in Statistics, with significant and relevant experience applying biostatistics in a consultancy role or commercial drug development environment. Minimum five years’ experience as a Senior Statistician in a CRO or pharmaceutical company. Prior experience providing statistical consultancy support within the clinical arena. Candidates with a general understanding of Pre-clinical and CMC would be considered an advantage. Hands-on experience of regulatory submissions, advising, developing, and reviewing SAPs, sample size calculations, and review and input of CSRs and statistical reports. Experience in trial design for decision-making and early drug developments, from standard design to more novel designs including Bayesian and adaptive designs and statistical input into supporting worldwide regulatory submission strategies including IND and NDA submissions. Providing statistical input/support into briefing books and Agency meeting preparation, with demonstrable experience interacting and meeting with regulatory agencies, including FDA, MHRA and EMA as a minimum and responses to regulatory questions. Experience in trial simulations, able to provide study simulations to improve the understanding of how unknown factors may impact on the clinical trial conduct and results. Knowledge of observation research methods, adaptive study design, and real-world data. Experience in development of PK/PD models, Bayesian inference, and adaptive design approaches. Machine learning/artificial Intelligence would be considered an advantage. Ability to apply a range of advanced statistical techniques in support of clinical research studies and to analyse, interpret, and draw conclusions from complex statistical information. Knowledge of statistical methods used in different therapeutic areas and be able provide statistical advice on best strategy to the overall development of the product and disease indication selection. Working knowledge of CDISC standards and application of these standards to projects, would also be considered an advantage. Capability to provide statistical leadership and consultancy to cross-functional teams and be able to communicate complex statistical techniques, methodology, and considerations to non-statisticians, clients, and other key stakeholders. Outstanding organisational and project management skills and ability to lead and run multiple simultaneous stats consultancy projects effectively. Demonstrated ability to grow, lead, and manage a small statistical team, in a fast-paced environment through managing multiple projects, and acting on initiative in a timely manner in order to meet deadlines. High level of computer literacy and competency in MS Office programs, knowledge of programming skills for statistical procedures and an understanding of statistical programming languages (e.g. R and SAS). Excellent interpersonal, verbal, presentation, and written communication skills (in English as a minimum). Willingness to work flexible hours and travel for short periods, sometimes at short notice, within the UK/Netherlands and Europe or internationally. Benefits A competitive salary, which is commensurate with experience. Generous bonus program, which rewards success. 26 days Holiday plus Birthday and Work Anniversary. 5% employer pension contribution/allowance. Enrolment/compensation of Private Healthcare insurance. Access to Employee Assistance Programme. Employee Ownership Trust Scheme. An opportunity to influence global business strategy, and associated implementation. A challenging and stimulating position for a dynamic and competent Statistical professional, who wishes to contribute to a growing business and a rapidly expanding team. Coaching and mentoring to support your continuous development. A unique working environment driven by strong company values and a very high level of employee engagement across the international organisation. As a Scendea Employee Part of what makes Scendea successful is the highly motivated people who work for us and their enthusiasm for what we do and stand for. We recruit individuals whose passion, drive, integrity, and customer orientation shines through. You are a motivated individual who can instil trust and confidence in our customer relationships whilst having a natural aptitude for getting the best out of people internally. You will inspire others through your commitment, motivation, expertise, professional manner and always placing the customer at the centre of everything you do. GatedTalent consolidates jobs from a variety of sources. Users of the “Talentis” and “FileFinder” executive search CRMs are able to publish jobs to the site with links from inside their core business apps. These are supplemented by jobs added by our own researchers and those provided by a third party job aggregation service. Please note that GatedTalent staff are not directly involved in the recruiting process.
#J-18808-Ljbffr