Senior​/Principal Clinical Data Scientist HTA

Senior/Principal Clinical Data Scientist HTA The Position

Biostatistics and Data Sciences (BDS) is a global organization within the Human Pharma Business Unit. By working in close collaboration with other functions at Boehringer Ingelheim and external vendors, we integrate methodological and technical data science skills with business and scientific expertise. Together, we drive smart, timely, and confident decision-making from Proof of Concept (PoC) to approval and access.

On our journey to transform BDS into a modern data science organization in clinical development our intent is to create a learning organization in which people develop and deploy leading-edge data science approaches and technologies to actively plan, generate and evaluate evidence that shapes informed decision-making along the value chain.

Our Clinical Data Scientists support drug development through regulatory approval, HTA, and Medical Affairs by providing strategic planning, data transformation, and all aspects of descriptive, diagnostic, predictive, and prescriptive analytics.

This position is located either in Ingelheim or Biberach and has a hybrid setup with approximately 1 day per week on site. This position can be filled either as Senior Scientist or Principal Scientist.

As Senior Clinical Data Scientist, you are responsible for national and regional HTA procedures (e.g., Germany, EU-HTA) with the focus on statistical evidence generation:

• You will collaborate within a cross-functional team to develop the optimal strategy for HTA procedures for our compounds, utilizing knowledge of HTA agency requirements and available evidence, while facilitating coordination and alignment throughout the organization.
• For HTA submissions, you will apply traditional statistical methods and combine them with cutting-edge data science methods in the design, collection, and analysis of clinical data from studies and projects. This includes situations requiring complex evidence synthesis, such as indirect comparisons and network meta-analyses – potentially including real world data.
• You will develop statistical standards for the analysis of clinical trials, considering the upcoming EU HTA regulation.
• Furthermore, you will contribute to the planning of clinical trials, including patient registries, to ensure that HTA needs are covered. In addition, you support Joint Scientific Consultations under the EU HTA regulation and national HTA authority consultations to obtain scientific advice prior to the start of the pivotal clinical trials with the goal to improve the quality and appropriateness of our clinical development program.
• You will stay current of the latest developments in statistical and data science methodologies, as well as HTA guidelines, requirements, and the upcoming EU HTA regulation.
• Moreover, you will collaborate closely with scientists and experts from various disciplines in clinical development and Market Access, both inside and outside BI.

• In addition, you will lead and oversee complex HTA projects.
• You will present and explain statistical analyses during HTA oral hearings and written statements.
• You will also develop and implement complex statistical methods involving the BDS therapeutic area and methodology statisticians.

• Doctoral Degree (PhD) in Statistics, Mathematics, Computer Science or related field with first relevant experience or Master of Science (MSc) with several years of relevant experience.
• Demonstrated experience in pharmaceutical development, including sound knowledge of statistical methodology, design of clinical trials, basic medical terminology, and processing clinical trial information are essential.
• Advanced knowledge of and hands‑on experience in relevant software languages, like SAS and R.
• Experience in working in/with agile teams and/or as a product owner is a plus.
• Ability to pro‑actively identify issues and solutions and to interact with internal and external bodies on routine clinical data science issues.
• Interpersonal skills with the ability to interact effectively with people, internally and externally as well as…