P2608 - Head of Biostatistics & Data Management

ppAre you passionate about advancing science and improving lives? We are currently looking for a driven, passionate and strategic leader to join our Biostatistics and Data Management department based at our Headquarters in Lausanne, Switzerland. /p h3Head of Biostatistics and Data Management /h3 pAt Debiopharm, we are driven by a singular mission: to develop for patients. As the Head of Biostatistics Data Management, you will play a pivotal role in this mission by leading a dedicated team of highly skilled professionals to provide cutting‑edge expertise to all our clinical programs. In this pivotal role, you will design and execute the innovative data strategy that underpins our clinical development pipeline, ensuring the highest standards of scientific rigor and regulatory compliance across all trials and study phases, fundamental to our global product registration efforts. /p h3Your Mission /h3 ul libStrategic Leadership and Team Development: /b ul liLead, align, and motivate the Biostatistics and Data Management organization to ensure unwavering commitment and engagement. /li liMentor a growing team of statisticians, data managers, and statistical programmers, and oversee collaborations with CROs and external vendors to deliver world‑class analytics and insights. /li liDrive organizational and talent development, along with resource planning, to secure the achievement of both short and long‑term goals. /li /ul /li libStatistical and Methodological Oversight: /b ul liSupervise and provide guidance on statistical design methodology across programs, including input to clinical development plans, trial protocols, SAPs, and CSRs, ensuring they comply with regulatory requirements. /li liLead the development and implementation of innovative statistical models and methods, keeping the team current with state‑of‑the‑art practices and global regulatory guidance. /li liPersonally perform the duties of a project statistician when required, providing input on study design, endpoints, sample size calculation, and reviewing Case Report Forms. /li /ul /li libRegulatory and Compliance Command: /b ul liTake responsibility for the statistical components of Clinical Trial Reports for all regulatory submissions. /li liSupervise and directly contribute to regulatory strategy and submission documents such as Briefing Books, NDA/CTD, and official responses to regulatory agencies. /li liDefine and ensure the compliance of all SOPs, standards, and templates with FDA, EMA, ICH, and CDISC guidelines. /li /ul /li libCross‑Functional Collaboration and Communication: /b ul liPartner cross‑functionally with Clinical Development, Clinical Operations, Regulatory Affairs, and Translational Medicine to shape study protocols, drive forward‑thinking statistical contribution, and guarantee data integrity through advanced systems and processes. /li liSupervise the preparation of oral and written reports to effectively communicate the results of clinical trials. /li liWork hand‑in‑hand with the Digital IT department to strategically evolve and maintain our digital platforms and tools that align with state‑of‑the‑art industry trends. /li /ul /li /ul h3Your profile /h3 ul liA Ph.D. in Statistics, Biostatistics, Mathematics, or a related field /li liA minimum of 12 years of experience in the biotech or pharmaceutical industry, with at least 8 years leading Biostatistics, Statistical Programming, and Clinical Data Management functions /li liProven expertise in clinical and pharmaceutical industry experience in planning and conducting clinical trials, preferably in early phase clinical development oncology studies within a pharmaceutical industry setting /li liDemonstrated expertise in statistical design and planning, data analysis, and reporting of clinical trial data /li liExtensive knowledge of GCP, ICH guidelines, FDA and EMA regulations /li liProven experience with eCTD NDA submissions /li liSolid, hands‑on knowledge of relevant statistical software like R, SAS is necessary /li liStrong appetite for Innovation, Digitalization and AI with hands‑on experience an asset /li liExceptional leadership, communication, and interpersonal skills, with the ability to thrive in a cross‑functional, matrix environment /li liHigh degree of motivation and a results‑oriented mindset are key, with the ability to work in a quickly changing environment /li liExcellent verbal and written communication skills in English /li /ul h3What we Offer /h3 ul liBeing part of a company where innovation, collaboration, and impact aren’t just values — they’re how we work every day /li liPartner with teams across disciplines, at the forefront of oncology and anti‑infective development /li liAn inclusive and respectful workplace — proud to be Equal‑Pay certified /li liGrow in a culture that values people, purpose, and performance /li liA chance to grow, share, and shape the future of healthcare /li /ul /p #J-18808-Ljbffr