Posted on Apr 6, 2021 by Boehringer Ingelheim
Independently design and analyze Global Innovation (GI) Development experiments at the site/regional level. This position is an active part of the network of non-clinical statisticians (NCS) and may input on projects on other sites with support and alignment of the Principal Statistician. Responsibilities include engaging directly with project teams and GI management to provide statistical expertise for research and development projects, regulatory submissions, and/or product release strategies. The incumbent represents BI at a regional level such as supporting Regulatory Affairs to prepare the industry position on methodologies and analysis related to our products. Demonstrated knowledge of regional regulatory policies related to study conduct and statistical analysis is required while remaining current on changes to existing industry guidelines. This position interacts directly with technical staff on the statistical methodologies in lab sciences and leads training programs at a regional/site level. Mentoring statistical interns may be required.
As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheims high regard for our employees.
Duties & Responsibilities:
Independently perform duties of project statistician by providing statistical designs and analyses that contribute to core group/research goals and reflect expert knowledge. Identify and implement new statistical methodologies that support more effective and efficient study conduct and approval. Responsible for statistical reports that meet regulatory requirements for submission to the agencies.
In depth understanding of site GI project objectives. Collaborates with scientists within and outside functional areas to achieve GI deliverables. Participate as representative on multiple project teams and contribute to defining statistical related aspects of overall program goals. Conveys analysis to Technical Development Leaders, scientists, and Regulatory Affairs.
Independently prepares clear technical reports and oral presentations. Clearly communicates results in for the form of complete documentation. Presents responsibly and defends own work at meetings. May deliver updates to function management in context of overall project goals. Upon request, contributes and presents project related topics within Regulatory forums (FDA/USDA).
Demonstrated competence to provide statistical guidance for multiple projects and implement new methodologies in support of priority projects.
Keeps abreast of relevant literature. Develops visibility outside of functional area and effectively interacts scientifically. Liaises internally with cross-functional stakeholders to communicate and align expectations. Ability to interpret current literature and convey relevance to development projects.
Develop sound personal relationships and partnerships within the statistics group, across multiple functions within BI, and applicable regulatory forums. Engage and collaborate with NCS network to share best practices. Develop and provide on-site training for non-statisticians.
Complies with all applicable regulations. Ensures that work performed is conducted in a safe and compliant manner. Maintains proper records in accordance with policies.
Individual will play a role in product development by implementation of data analysis systems, project management skills, time projections, and the ability to directly interact with regional Regulatory affairs.
Ph.D. from an accredited institution in statistics, biostatistics, or mathematics with sound statistical theory and application of relevant methodologies in study design and analysis with minimum of three (3) years of nonclinical statistical focus in the pharmaceutical/biological industry and/or Regulatory Authorities. Alternatively, M.S. from an accredited institution in the above mentioned areas with at least seven (7) years of industry experience.
Knowledge of statistical methodology and its application to lab sciences in biologics and/or pharmaceutical development.
Relevant statistical software programs for data management, analytics, multivariate analysis, and predictive analysis
Ability to communicate effectively to non-statisticians.
Excellent oral and written communication skills.
Ability to write statistical aspects of study protocols, study reports, and publications.
Ability to interact and negotiate with regulatory affairs, project leaders, and lab leaders on statistical issues.
Ability to work effectively as part of a team and manage project from a statistical perspective.
Solid understanding of cGMP guidelines.
Ability to work with scientists and function management to determine the most effective and efficient design to address project objectives.
Should have skills and abilities beyond the demonstration phase, play a role in organization relative to statistical methodologies in development of new products, technology development, regulatory knowledge and project management.
Appropriate level of understanding and use of applicable regulations governing the Animal Health Industry.
Strong communication skills in working with internal stakeholders.
Ability to manage projects and resources from start to finish
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