Expert or Senior Principal Statistical Advisor

vor 3 Wochen

Munich, Deutschland BI Pharma GmbH&Co.KG Vollzeit

**The Position**:
Biostatistics and Data Sciences (BDS) is a global organization with more than 400 employees within the Human Pharma Business Unit. Working in close collaboration with other functions at Boehringer Ingelheim (BI) and external vendors we combine methodological and technical data science skills with business and scientific expertise to drive smart, timely and confident decision making at every stage of the drug development lifecycle.

On our journey to transform BDS into a modern data science organization in clinical development that is capable to thrive in a world of rapid and continuous change we are further enhancing our footprint at the therapeutic area and methodology level. For this purpose, we are extending our expertise on statistical aspects related to market access and medical affairs topics.

In your role of a Statistical Advisor for market access and medical affairs topics, you work on a cross-therapeutic area (TA) level. You provide state-of-the-art statistical expertise on multiple of the following focus topics:
- complex evidence synthesis (including Bayesian network meta-analysis),- patient-focused drug development (including clinical endpoint development and psychometric validation of instruments),- Integration of real-world (and other trial-external) data into clinical development and HTA reports e.g. via usage of Bayesian borrowing- planning and conduct of HTA reports in line with current HTA guidance by international authorities- surrogate endpoint validation,- subgroup analysis in the context of medical affairs and HTA,- health economics evaluation and decision modeling- phase IV trial design (including comparative effectiveness and safety research, and post-marketing requirements and commitments), and- post-hoc clinical trial data analyses for publication in the medical literature and effective communication of clinical trial data analyses with scientific and medical communities, as well as patient organizations. You develop/contribute to related strategies from a data science/statistical methodological perspective. You consult BDS clinical development teams to support the implementation of these strategies. Close collaboration with other company-internal stakeholders such as the Global Market Access, Global Medical Advisors, and Global Epidemiology is a key factor for the success of your work.

**Tasks & Responsibilities**:
- You develop and contribute to cross-TA and TA specific statistical strategies related to the topics listed above. You facilitate their implementation into statistical software.- You support Clinical Development teams on related tasks. For example, analysis of RWD that can be used to support trial planning and statistical validation of PROs.- You collaborate with other BDS and non-BDS functions on driving statistical/methodological innovation with respect to related aspects.- You evaluate innovative statistical methods for related areas e.g., via simulation. You transform promising methods into ready-to-use toolkits and promote broad usage of existing or newly developed innovative, complex statistical methods.- You drive and plan related trainings to statisticians and non-statisticians. You mentor colleagues on the technical-methodological track.- You collaborate with academic experts via initiation and supervision of PhD, MSc. and BSc. student projects on applied statistical methodology/statistical software related topics and represent BDS in joint research proposals.- You participate in international BI working groups on standardization, implementation and innovation of statistical methodology and software development. You represent BDS and chair & participate in cross-functional working groups, projects, and conferences on related topics.- You identify upcoming trends and requirements in the areas mentioned above and lead their implementation.

Additional tasks and responsibilities as Expert:
- Identify and conceptualize training needs for statisticians and non-statisticians.- Initiate, lead or contribute to cross-functional BI internal working-groups or lead cross-functional human pharma internal working-groups and drive/plan relevant statistical aspects. Lead or contribute to external working groups.- Identify and initiate trends in data science and in particular statistics within and outside BI.**Requirements**:
- PhD or Master’s degree in Statistics or Mathematics or a related field (Pharmacoepidemiology, Data Science, Health Economics, etc.). At least seven years of experience as a statistician or data scientist. Working experience might be compensated by broad and deep topic-specific knowledge with respect to to the focus area.- Experience as project statistician and advanced knowledge of clinical development (in particular for medical affairs and market access) is a plus.- In-depth knowledge of statistical methodology related to the focus area.- In-depth knowledge on the non-statistical aspects of the focus area.- Hand-on experiences an

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