Job Title
Director Statistical Scientist - 2440678
Job Profile
The Director Statistical Scientist will provide strategic statistical scientific global leadership to the clinical development programs, comprising all relevant technical and disease area knowledge. In this position the incumbent will drive and steer the strategic quantitative framework for (pre/early/full-) clinical programs in close collaboration with (early) project teams. This position represents the GPT internally and externally as the statistical scientist with leading quantitative skills, including regulatory interfaces, with objective and transparent program quantitative risk/probability of success assessments. In collaboration with clinical counterparts (Global Brand/Project Medical Directors/ Translational Medicine Experts) and Global Project Teams, influence and negotiate clinical development plans (CDPs/TPPs) leads the quantitative evaluation of competing program/trial/analysis strategies assuring robust clinical development planning and execution. Defines and drives statistical strategic and quantitative contributions to regulatory/submission strategy and related documents (e.g.: Target Product Profile, sPOC document, CDP, Briefing Books, Risk Management Plan and responds to HA questions), drives the full integration of modern aspects of drug development including model-based drug development and statistical methodologies in collaboration with partners, facilitates and manages internal and external stakeholders through to PoC/DDP or regulatory acceptance. Drives and coordinates the synthesis and integration of information to support transition of drug development milestones / decision boards. Identifies alternative strategic options to risk mitigate programs – thus limiting potential negative impact on (pre/early/full-) program success. Leads statistical scientific evaluation of in-licensing opportunities and represents IIS at project level internal/external meetings with respect to statistical scientific input and in portfolio level governance boards (e.g TM forum, IFB). Will ensure full integration of Statistical Methodology and make sure that the IIS team (biometrician, data management, database programming, statistical programming, medical and scientific writing are aligned. This position interacts with Health Authorities and external key opinion leaders as the recognized Company expert at the program (or equivalent) level for all quantitative aspects of the program and represents IIS at across global regulatory hearings/advisory committee meetings and other global regulatory interfaces.
Required skills:
PhD in Statistics (or equivalent degree/knowledge) and 8 years industry experience. 4 years influencing (pre/early/full-) clinical development programs establishing, and regulatory approvals with global leadership of the statistical sciences within the development plans, within at least one indication/disease area. Strong disease area and guidelines knowledge is required. Contributes to external white-papers/policy shaping best practice statistical science. Has strong and established track record of developing/establishing statistical excellence and established experience in leading global scientific improvement/change initiatives. Must have strong interpersonal and communication skills (verbal and writing) bridging scientific and business needs – integrating quantitative sciences, strong disease area knowledge and appropriate market/competitive intelligence.
Expert scientific leadership skills demonstrated in facilitating and optimizing the (pre/early/full-) clinical development strategy and a strong track record for global scientific leadership in the development and evaluation of modern program/trial design methodologies.
A natural modern leadership style building partnerships and collaborative environments and expert skills to facilitate and maximize the contribution of quantitative team. Hands-on experience in leading the interface to regulatory agencies/leading the early clinical development campaign
required. Must be f
luent in English both oral and written.
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Location: USA-NJ |
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Posted on
Aug 17,2026 |
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Company info
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