Apply on Employer Site

Boehringer Ingelheim · 2 weeks ago

SR AD/ AD, Principal Clinical Data Scientist -Early Oncology Drug Development (Remote)

United States

Full-time

Remote

Senior Level, Lead/Staff

$140K/yr - $222K/yr

6+ years exp

Boehringer Ingelheim is a global leader in biopharmaceuticals, and they are seeking a Principal Clinical Data Scientist to support early Oncology drug development. The role involves strategic planning, execution of clinical trial designs, and analytics of clinical project data while collaborating with cross-functional teams.

BiotechnologyHealth CareMedicalPharmaceutical

Comp. & Benefits

No H1B

Responsibilities

Lead and oversee designing, transforming, analyzing and reporting complex early Oncology clinical trials or projects with established BI experience

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 BI. 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 BI

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 by ensuring statistical rigor in evidence strategies

Participate in cross-functional BI 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

Subject Matter Expert (SME) / Process Lead for designing, transforming, analyzing and reporting complex early Oncology clinical trials or projects, that represent new challenges and for which project and therapeutic knowledge is not given

Subject Matter Expert (SME) / Process Lead for designing as well as transforming, analyzing and reporting of other data that represent new challenges from research and development like registries and real-world databases

Identify trends in data science within and outside BI

Lead cross-functional BI internal working-groups and drive/plan relevant data science aspects

Foster innovative digital approaches to produce sophisticated, intelligent optimization solutions, innovative processes and predictive models

If applicable, supports the clinical drug development process up to the level of Therapeutic Area/assets

Qualification

Clinical trial designData science methodologiesStatistical analysisOncology knowledgeSoftware languagesStatistical methodologyProject leadershipTraining developmentCross-functional collaborationCommunication skillsTeam player

Required

Bachelor of Science with a minimum of seven (7) years; Or Master of Science with six (6) years of experience OR Doctoral Degree (PhD) with three (3) years, all must be from an accredited institution in Statistics, Mathematics, Computer Science or related field (Psychology, Data Science, Finance, etc.). Experience can be from 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 and understanding of clinical trial development process required

Advanced project lead experience required

Understanding and applying key principles of data science

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

Demonstrated broad knowledge in planning, transforming, analyzing, interpreting, and reporting data in complex clinical trials, in projects with established BI experience or data from other sources in clinical research and development

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

Advanced working knowledge of broad variety of aspects of relevant software languages

Ability to lead and facilitate meetings as well as develop and deliver trainings related to data science

Language skills: English: fluent (Read/Write/Speak)

Know, understand, and implement international regulations and guidelines for good clinical and statistical practice from all ICH regions

Know, understand, and implement the various international guidelines on clinical development, including statistical methodology, for TA-related disease areas

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

Bachelor of Science with a minimum of ten (10) years; Or Master of Science with ten (10) years of experience OR Doctoral Degree (PhD) with six (6) years, all must be from an accredited institution in Statistics, Mathematics, Computer Science or related field (Psychology, Data Science, Finance, etc.). Experience can be from within the pharmaceutical industry, CROs, regulatory authorities or academic institutions

Demonstrated comprehensive knowledge in planning, transforming, analyzing, interpreting, and reporting data in complex situations that represent new challenges and for which project and therapeutic knowledge is not given

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

Advanced understanding of cutting-edge statistical concepts related to Data Science

Comprehensive working knowledge of broad variety of aspects of relevant software languages

Must be legally authorized to work in the United States without restriction

Must be willing to take a drug test and post-offer physical (if required)

Must be 18 years of age or older

Preferred

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

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

Benefits

Role specific variable or performance based bonus

Other compensation elements

Company

Boehringer Ingelheim

Glassdoor4.2

Boehringer Ingelheim is a group of pharmaceutical companies that focuses on prescription medicines and animal health. It is a sub-organization of Boehringer Ingelheim.

Founded in 1885

Ingelheim Am Rhein, Rheinland-Pfalz, DEU

10001+ employees