P2608 Head of Biostatistics & Data Management

At Debiopharm every step we take is guided by one purpose: improving the lives of people affected by cancer and infectious diseases. As a privately-owned Swiss biopharmaceutical company were driven by science but above all by the people behind every treatment the patients and their families.

Through our unique development only model we bring forward promising therapies and transform them into treatments that can reach those who need them most faster.

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 as

Head 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 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 crossfunctionally 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.

More than a checklist of skills were looking for someone who shares our commitment to science with purpose.

Your profile

A Ph.D. in Statistics Biostatistics Mathematics or a related field

A 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

Proven 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

Demonstrated expertise in statistical design and planning data analysis and reporting of clinical trial data

Extensive knowledge of GCP ICH guidelines FDA and EMA regulations

Proven experience with eCTD NDA submissions

Solid hands-on knowledge of relevant statistical software like R SAS is necessary

Strong appetite for Innovation Digitalization and AI with hands-on experience an asset

Exceptional leadership communication and interpersonal skills with the ability to thrive in a cross-functional matrix environment

High degree of motivation and a results-oriented mindset are key with the ability to work in a quickly changing environment

Excellent verbal and written communication skills in English

What we Offer:

Being part of a company where innovation collaboration and impact arent just values theyre how we work every day

Partner with teams across disciplines at the forefront of oncology and anti-infective development

An inclusive and respectful workplace proud to be Equal-Pay certified

Grow in a culture that values people purpose and performance

A chance to grow share and shape the future of healthcare

What to Expect in the Recruitment Process:

If your application is selected youll be invited to interviews with Talent Acquisition and the Hiring Manager via Teams followed by a panel interview and reference checks. Communication is handled via Workablecheck your spam folder for emails from *@.

Please contact our HR Department prior to submitting any profiles. We cannot accept unsolicited applications from agencies or recruiters.

Required Experience:

Director