Head of Biostatistics

Head of Biostatistics & Data Management 100 %

Please ensure you read the below overview and requirements for this employment opportunity completely.
Debiopharm International SA Vacant since : Number of jobs : 1 1006 Lausanne (VD) 100% Immediately Permanent

Lien : latest-open-positions

Are 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 asHead of Biostatistics and Data Management.

At 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.

Your Mission :

Strategic Leadership and Team Development:Lead, align, and motivate the Biostatistics and Data Management organization to ensure unwavering commitment and engagement.Mentor 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.Drive organizational and talent development, along with resource planning, to secure the achievement of both short and long-term goals.Statistical and Methodological Oversight:Supervise 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.Lead the development and implementation of innovative statistical models and methods, keeping the team current with state-of-the-art practices and global regulatory guidance.Personally perform the duties of a project statistician when required, providing input on study design, endpoints, sample size calculation, and reviewing Case Report Forms.Regulatory and Compliance Command:Take responsibility for the statistical components of Clinical Trial Reports for all regulatory submissions.Supervise and directly contribute to regulatory strategy and submission documents such as Briefing Books, NDA/CTD, and official responses to regulatory agencies.Define and ensure the compliance of all SOPs, standards, and templates with FDA, EMA, ICH, and CDISC guidelines.Cross-Functional Collaboration and Communication:Partner 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.Supervise the preparation of oral and written reports to effectively communicate the results of clinical trials.Work 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. xumlcvs More than a checklist of skills, we’re looking for someone who shares our commitment to science withpurpose.

Your profile :

A Ph.D. in Statistics, Biostatistics, Mathematics, or a related fieldA 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 functionsProven 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 settingDemonstrated expertise in statistical design and planning, data analysis, and reporting of clinical trial dataExtensive knowledge of GCP, ICH guidelines, FDA and EMA regulationsProven experience with eCTD NDA submissionsSolid, hands-on knowledge of relevant statistical software like R, SAS is necessaryStrong appetite for Innovation, Digitalization and AI with hands-on experience an assetExceptional leadership, communication, and interpersonal skills, with the ability to thrive in a cross-functional, matrix environmentHigh degree of motivation and a results-oriented mindset are key, with the ability to work in a quickly changing environmentExcellent verbal and written communication skills in English

Work location

1006 Lausanne (VD)

Workload

100%

Employment start

Immediately

Employment duration

Permanent

Qualification

skilled

Work experience

More than 3 years

Education

Doctorate from a university or equivalent

English

Orally : Very g