Senior Manager Biostatistics, Early Phase (m/f/d)

Daiichi Sankyo Co.; France; Remote; EUR 140.000 - 180.000; Vollzeit

Zusammenfassung

Daiichi Sankyo seeks a Senior Manager Biostatistics, Early Phase to lead complex early-phase studies (dose-escalation, expansion and optimization) in design, analysis, interpretation and reporting. You’ll serve as the main statistical contact for assigned studies and collaborate with cross-functional teams to enable development decisions.

Requirements include a Master’s in statistics/biostatistics (PhD preferred), 8+ years in pharma with early-phase exposure, and strong SAS and/or R skills.

Qualifikationen

• Master’s degree in statistics or biostatistics required; PhD preferred.
• 8+ years of relevant pharma experience with master’s; 5+ years with PhD preferred.
• Strong written and verbal communication skills.
• Proficiency in SAS and/or R.

Aufgaben

• Lead statistical activities for early-phase studies (dose-escalation, expansion, optimization).
• Provide statistical leadership to development plans and regulatory documentation.
• Act as the main statistical contact for assigned studies and collaborate with cross-functional teams.
• Oversee CRO/vendor statistical activities and ensure quality and timeliness of outputs.
• Support Health Authority submissions with statistical rationale and analyses.

Kenntnisse

Bayesian methods

Adaptive designs

Dose-finding

Modeling and simulation

Communication skills

Cross-functional collaboration

Statistical leadership

Ausbildung

Master's degree in statistics or biostatistics

PhD in statistics or biostatistics (preferred)

Tools

SAS

R

Jobbeschreibung

Senior Manager Biostatistics, Early Phase (m/f/d)

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Language View Profile Employee Login Job Description Job Title: Senior Manager Biostatistics, Early Phase (m/f/d) Job Requisition ID: 2321 Posting Start Date: 10/9/26

At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society.

Job Summary

This position supports early-phase development and leads complex studies up to POC (proof of concept), including dose-escalation, dose-expansion, and dose-optimization studies, in study design, statistical analysis, interpretation, and reporting of results. This position contributes to drug development plans and Health Authority documents while independently providing statistical leadership for assigned studies. This position serves as the main statistical contact for assigned studies and collaborates with cross-functional study and project teams to solve complex study problems. The position provides scientific oversight of delegated CRO statistical activities while retaining accountability for the quality and timeliness of statistical deliverables. This position partners closely with Early Development study and project teams, including Clinical Development, Clinical Science, Clinical Pharmacology, Precision Medicine, Translational Science, Clinical Operations, and other relevant functions, to support study execution, data interpretation, and development decision-making. The primary location for this position is France, with Germany as the secondary location.

Responsibilities

• Protocol Development, Case Report Form (CRF; review), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR):

  • Leads statistical activities for complex early-phase studies, including dose-escalation, dose-expansion, and dose-optimization design; protocol development; CRF review; SAP and analysis specification development; statistical analysis quality review; results interpretation; and CSR input and review.

  • Acts as the main statistical contact for the assigned studies and projects.

  • Provides statistical guidance to study and project teams and contributes to the evaluation and integration of emerging safety, tolerability, efficacy, pharmacokinetic/pharmacodynamic, and biomarker data to support dose escalation, dose selection, cohort expansion, and development decisions; collaborates closely with data management and statistical programming to ensure high-quality data and outputs.

• Drug Development Strategy: Provides statistical input to early development plans and decisions, including dose and schedule selection, cohort expansion, proof-of-concept assessment, and advancement decisions, to ensure study designs are scientifically sound, fulfill regulatory requirements, and support the evaluation of the pre-specified drug product profile.

• CRO / Vendor Oversight: Provides scientific and technical oversight of delegated CRO/vendor statistical activities and ensures deliverables meet quality, compliance, and timeline expectations.

  • Reviews CRO/vendor proposals and budgets.

• Global Health Authority Support: Contributes to the statistical content of global Health Authority documents and responses for assigned studies and may participate in Health Authority meetings or teleconferences to support the statistical rationale for study design, dose optimization, analysis, and decision criteria.

• Global BDM Strategy to Improve Drug Development: Primarily participates in and may occasionally lead moderately complex initiatives, with some level of supervision, to improve the harmonization and efficiency of drug development, which leads to cost savings and shortened timelines for the companys.

Qualifications

Education Qualifications

• Master’s degree in statistics or biostatistics required, and PhD in statistics or biostatistics preferred.

Experience Qualifications

• 8+ years of relevant experience in the pharmaceutical industry with a master’s degree required, or 5+ years of relevant experience in the pharmaceutical industry with a PhD preferred.
• A minimum of 2 years of experience supporting Early Phase drug development studies, including dose-escalation, dose-expansion, dose-optimization, or proof-of-concept studies, preferred.
• Strong written and verbal communication skills.
• Proficiency in SAS and/or R required.
• Experience applying statistical methodologies relevant to Early Phase development, including Bayesian methods, adaptive designs, dose-finding approaches, modeling and simulation, and decision-making statistical frameworks such as futility assessment, preferred.
• Demonstrated ability to provide real-time statistical consultation and recommendations in fast-paced, cross-functional discussions. Demonstrated ability to evaluate and discuss multiple statistical design options and support the selection of fit-for-purpose development strategies preferred.

Travel Requirements

Ability to travel up to 10% of the time.

Why work with us?

Working at Daiichi Sankyo is more than just a job – it is your chance to make a difference and change patients’ lives for the better. We can only achieve this ambitious goal together. That is why we foster a culture of mutual respect and continuous learning, with a strong commitment to inclusion and diversity. Here, you will have the opportunity to grow, think boldly, and contribute your ideas. If you have a proactive mindset and passion for addressing the needs of patients, we eagerly await your application.

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