Senior Clinical Data Scientist | Staff |医薬開発本部エクスペリメンタルメディシンジャパン (Shinagawa, Japan, Tokyo)

Description

Support the early Oncology clinical drug research and development process by providing strategic planning and execution, including clinical trial design and all aspects of descriptive, diagnostic, predictive and prescriptive analytics of data related to clinical projects like actual trial data, registries and real-world data bases.

Represent biostatistics and coordinate the inputs from programing and data management at a substance/asset level regarding data science related aspects.

Collaborate with cross-functional teams to design, evaluate, and optimize clinical trial strategies and development scenarios.

As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers.

Duties & Responsibilities

• Lead and oversee designing, transforming, analyzing and reporting complex early Oncology clinical trials or projects.

• Lead and oversee for designing, transforming, analyzing and reporting of other data from research and development like registries and real-world data bases with respect to a specific use case or project/asset.

• Develop and implement fit-for-purpose statistical designs and Go/NoGo decision frameworks through simulations and scenario planning to ensure high-quality evidence generation.

• Keep abreast of data science within and outside Boehringer. Apply advanced statistical methodologies and turn derived insights into new data science approaches for early Oncology clinical development.

• Support fostering innovative digital approaches to produce sophisticated, intelligent optimization solutions, innovative processes and predictive models.

• Present compelling validated stories regarding complex data science aspects to Biostatistics colleagues and other professionals within and outside of Boehringer.

• If applicable, supports the clinical drug development process up to the level of substance/assets.

• Guide and/or lead other colleagues, internal and external customer and external providers on data science related tasks.

• Coordinate cross-functional working with programming and data management.

• Be a team player and contribute to cross-functional collaborations.

• Supports regulatory interactions with major health authorities including FDA, EMA, and PMDA, by ensuring statistical rigor in evidence strategies.

• Participate in cross-functional Boehringer internal working-groups and drive/plan relevant data science aspects. Participate in external working groups.

• Liaise with late phase Oncology Biostatistics and Data Science team to leverage synergies and share knowledge.

Requirements

• Bachelor of Science (BSc) from an accredited institution in Statistics, Mathematics, Computer Science or related field (Psychology, Data Science, Finance, etc.), with a minimum seven (7) years of data science experience; Or

• Master of Science (MSc) from an accredited institution in Statistics, Mathematics, Computer Science or related field (Psychology, Data Science, Finance, etc.), with six (6) years of experience within the pharmaceutical industry, CROs, regulatory authorities or academic institutions; Or

• Doctoral Degree (PhD) from an accredited institution in Statistics, Mathematics, Computer Science or related field (Psychology, Data Science, Finance, etc.), with three (3) years of experience within the pharmaceutical industry, CROs, regulatory authorities or academic institutions.

• Working experience might be partially compensated by broad and deep topic-specific knowledge.

• Broad knowledge and advanced experience in software languages relevant for business needs.

• Advanced project lead experience required.

• Understanding and applying key of principles of data science.

• In-depth understanding of advanced statistical concepts related to Data Science.

• Thorough knowledge of statistical methodology, design of clinical trials or clinical experiments, basic medical terminology and on processing clinical trial information.

• Mindful of local, global, internal and external cultures to ensure that messages are received positively and effectively.

• Ability to lead and facilitate meetings.

• Ability to develop and deliver training related to data science topics.

• Evidence of strong teamwork, also in global and remote context.

• Good interpersonal skills with the ability to interact effectively with people, internally and externally (e.g. CROs, experts, management).

• Ability to pro-actively identify issues and solutions and to interact with internal and external bodies on routine data science issues.

• Fluency in English and Japanese (Read/Write/Speak).

• Know, understand, and implement:

• International regulations and guidelines for good clinical and statistical practice from all ICH regions,

• The various international guidelines on clinical development, including statistical methodology, for TA-related disease areas, and

• BI processes and SOPs that govern clinical development in particular with respect to strategic areas (e.g. Clinical Development Plan).

Preferred Qualifications

• Basic medical understanding of Oncology disease areas, including familiarity with clinical endpoints, RECIST, cancer-related terminology, and therapeutic strategies.

• Familiarity with Oncology translational endpoints (e.g., exploratory or early surrogate markers) and statistical modeling for translational research.