Associate Director Biostatistics

Planet Pharma; Lavamünd; Vor Ort; EUR 156.000 - 209.000; Vollzeit

Zusammenfassung

Planet Pharma seeks an experienced Associate Director, Clinical Biomarker Biostatistics to lead statistical strategy across biomarker programs, shaping plans for patient stratification, companion diagnostics, and precision medicine. You will provide strategic and hands‑on leadership, influencing study design and regulatory submissions.

Role requires deep biomarker analytics expertise, experience with high‑dimensional data, and ability to mentor statisticians while collaborating with Clinical

Qualifikationen

• PhD or MSc in Statistics, Biostatistics, Mathematics, Bioinformatics, or a related quantitative discipline.
• Significant experience in pharmaceutical, biotechnology, or healthcare research environments.
• Extensive experience supporting biomarker development within clinical drug development programs.
• Deep understanding of statistical methodologies for biomarker research and precision medicine.

Aufgaben

• Lead the statistical strategy for clinical biomarker development across multiple programs and therapeutic areas.
• Design and implement statistical methods for exploratory, predictive, prognostic, translational, genomic, proteomic, and other high‑dimensional biomarker data.
• Develop biomarker analysis plans, statistical sections of protocols, and regulatory submission documents.
• Review and oversee statistical outputs, analyses, and interpretation of biomarker data generated by internal teams and external partners.

Kenntnisse

Biostatistics

R

SAS

Clinical trial design

Regulatory interactions

Ausbildung

PhD in Statistics/Biostatistics

MSc in Biostatistics/Statistics

Tools

R

SAS

Jobbeschreibung

We are seeking an experienced and highly motivated Associate Director, Clinical Biomarker Biostatistics to play a pivotal role in advancing our clinical development and precision medicine strategies. This is an exciting opportunity for a strategic and hands‑on biostatistician to drive the statistical leadership of biomarker initiatives across a diverse clinical portfolio.

As a key member of the Biometrics organization, you will partner closely with Clinical Development, Translational Medicine, Bioinformatics, Biomarker Sciences, and Regulatory teams to develop and execute biomarker strategies that inform critical drug development decisions. You will provide both scientific leadership and technical expertise, ensuring robust statistical methodologies are applied throughout the biomarker lifecycle, from early clinical development through registration.

Key Responsibilities

Strategic Leadership

• Lead the statistical strategy for clinical biomarker development across multiple programs and therapeutic areas.
• Shape and influence biomarker plans that support patient stratification, companion diagnostics, treatment response, pharmacodynamics, and precision medicine approaches.
• Serve as a strategic advisor to cross‑functional development teams on biomarker‑related study design, analysis, interpretation, and decision‑making.
• Contribute to the development of enterprise‑wide standards, methodologies, and best practices for biomarker statistics.
• Represent Biometrics in governance forums and senior‑level cross‑functional discussions.

Technical and Operational Excellence

• Provide hands‑on statistical leadership for biomarker analyses within clinical trials.
• Design and implement statistical methods for exploratory, predictive, prognostic, translational, genomic, proteomic, and other high‑dimensional biomarker data.
• Develop biomarker analysis plans, statistical sections of protocols, and regulatory submission documents.
• Review and oversee statistical outputs, analyses, and interpretation of biomarker data generated by internal teams and external partners.
• Collaborate with programmers and data scientists to ensure efficient analytical workflows and high‑quality deliverables.
• Support regulatory interactions and responses related to biomarker strategy and analyses.

Cross‑Functional Collaboration

• Partner closely with Translational Medicine, Clinical Pharmacology, Data Science, Bioinformatics, and Clinical Development teams.
• Translate complex statistical concepts into clear scientific recommendations for both technical and non‑technical stakeholders.
• Mentor and coach statisticians working on biomarker initiatives.
• Build strong relationships with external experts, academic collaborators, and CRO partners.

Required Qualifications

• PhD or MSc in Statistics, Biostatistics, Mathematics, Bioinformatics, or a related quantitative discipline.
• Significant experience in pharmaceutical, biotechnology, or healthcare research environments.
• Extensive experience supporting biomarker development within clinical drug development programs.
• Deep understanding of statistical methodologies for biomarker research and precision medicine.
• Expertise in clinical trial design and analysis.
• Strong knowledge of regulatory expectations related to biomarker and companion diagnostic development.
• Advanced proficiency in statistical programming and analysis tools such as R and/or SAS.
• Demonstrated ability to influence cross‑functional teams and senior stakeholders.
• Excellent communication and scientific presentation skills.

Preferred Qualifications

• Experience supporting immunology, rare disease, or other biomarker‑rich therapeutic areas.
• Knowledge of genomics, transcriptomics, proteomics, and real‑world data applications.
• Experience contributing to regulatory submissions and health authority interactions.
• Track record of scientific publications and conference presentations.
• Previous leadership or mentoring experience within a matrix environment.

What You’ll Bring

• Scientific curiosity and a passion for innovation.
• The ability to balance strategic thinking with hands‑on execution.
• Strong business acumen and decision‑making capability.
• A collaborative mindset and proven influencing skills.
• A commitment to delivering high‑quality science that improves patient outcomes.

About Planet Pharma

Planet Pharma is an American parented Employment Business/Agency that provides global staffing services with its head‑quarters in Chicago and our EMEA regional office located in Central London. We have invested significantly in creating a robust international platform that enables us to work compliantly in 30+ countries with a current network of 2500+ active contractors globally as well as a very strong permanent / direct hire recruitment offering.

Our specialist knowledge and close relationships with our clients and the wider industry really makes us unique in our field. Just recently we were recognised by FORBES as the 17th best professional staffing firm, and have won multiple awards from industry accredited bodies for our commitment to excellence and service delivery. We have extensive functional expertise including: Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions experts, Clinical development, Quality, Biostatistics, and Medical Affairs / Writing.

We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age.