Provides advanced statistical support for multiple complex global and regional Global MSAT projects, from registration phase through post-approval lifecycle management. Primary scope of work includes initiating, executing, and defending advanced statistical properties relative to biopharmaceutical processes and quantitative testing methodologies and their extensions. The Senior Biostatistician consistently contributes statistical expertise and represents the department and company to external entities. The Sr. Statistician is expected to be a proficient expert in the use of statistics and data sciences; to work independently and coordinate data acquisitions and data management efforts necessary to perform rigorous modeling, interpret results, and autonomously prepare study reports with appropriate business acumen for stakeholder interpretations and implementations. The Sr. Statistician should be an expert in the application of generalized linear modeling, time-series multivariate statistics including Principal Components Analysis and Partial Least Squares, QC test method validations and transfer validations, ANOVA/means comparisons, design of experiments, hypothesis and equivalence testing, protocol development, specification determination, and Statistical Process Control (SPC) methodologies. This position is expected to collaborate and represent Global MSAT Data Analytics best practices to promote a broad statistical ecosystem that delivers financial business value.
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 Ingelheim's high regard for our employees. Duties & Responsibilities\:
- Execute the duties of project and program statistician for complex studies technical transfers, process and testing qualifications, and provide support that reflects a high level of biomathematics knowledge. Collaborate with Global MSAT Data Analytics management, team, and stakeholders, to set and achieve project goals. Assumes departmental responsibility for multiple projects; capable of working independently to deliver objectives in a timely manner; and capable of compiling industry standard statistics reports suitable for internal compliance and/or regulatory submission.
- For projects and indications of increasing complexity, provide statistical support for technical transfer, process optimizations, process performance qualification, assay transfers and validations, in compliance with BIAH/regulatory guidelines, including\:
- Drive statistical aspects of study design, implementation, and execution.
- Identify and implement new statistical methodologies that support more effective and efficient project executions across multiple sites and programs.
- Manage study parameters to provide optimally-sized studies which will provide sufficient data for regulatory submissions without rework, waste, or unnecessary resource expenditure.
- Analyze process development and product performance study data using the appropriate methodologies while documenting and validating the programs required; report the results.
- Perform exploratory, descriptive, inferential, and predictive analyses; work with stakeholder interpretation, and present the results.
- Ensure regulatory (FDA, USDA, CVM, EMA, etc.) requirements regarding Biostatistics issues are fulfilled.
- Answer Regulatory questions regarding Biostatistics matters and interact with regulatory bodies.
- Clearly communicate statistical aspects of complex statistics validation and process performance statistics registrations, lifecycle management, publication, and for management to ensure appropriate interpretation of results, decision-making, and acceptance for approvals. Defend results and respond to questions.
- Apply broad knowledge of statistics including the ability to interpret current literature relevant to MSAT projects and to influence industry and regulatory agencies in the application of new methodologies. Provide example and indirect leadership for junior team members. Interact with externals on Biostatistics matters.
- Cultivate sound partnerships with internal and external stakeholders and colleagues. Utilize expertise and relationships to facilitate a strong negotiation position on project-related issues. Engage and collaborate with international colleagues to promote international harmonization. Participate in internal or external working groups; may lead internal working groups.
- Comply with company SOPs and relevant regulatory guidances at national and international levels. Act at all times within industry, company, and statistical standards and ethics. Apply solid understanding of relevant regulations governing the Animal Health industry. Lead in applying relevant regulations governing the Animal Health Industry and exhibit excellent communication skills in working with regulatory agencies.
- An individual in this position is responsible for the statistical aspects of complex biprocess sciences and analytical testing techniques and qualification projects. The incumbent's influence can have a significant impact on the duration and size (cost & resources) of technical transfers, process analytics, and advanced data science programs.
- The incumbent must\:
- Balance and prioritize project work according to business objectives. Balance multiple competing global and regional projects of varying complexity and prioritize project work within the group according to business objectives.
- Interact with counterparts in other divisions and regions.
- Ensure work is compliant with applicable regulatory requirements which vary by geographic region and agency.
- Research, justify, and apply innovative approaches when needed to analyze complex data or solve problems.
- Represent the Company (from a statistical perspective) to regulators, external researchers, industry groups, and the like.
Desired Experience, Skills, and Abilities\:
- Doctoral degree (preferred) from an accredited institution, with seven (7) years of biopharmaceutical experience; OR
- Masters degree from an accredited institution in Statistics/Biostatistics, with ten (10) years of bio-pharmaceutical experience.
- Experience in the pharmaceutical, animal health, or agricultural science industry is required and should include process and testing validation design and analysis as well as demonstrated knowledge of the pharmaceutical/biological life cycle process.
- Experience in project/program management; able to manage projects and resources from start to finish.
- Required software proficiency\: SAS, R, python, JMP, MS Office applications. In particular, demonstrated ability in SAS programming and R, supporting the analysis of data using linear mixed models, generalized linear mixed models, survival and categorical methods.
- Preference will be given to candidates with advanced knowledge of principal components analysis and partial least squares modeling of time series process data using software such as SIMCA, SIMCA-online, Unscrambler, Process Pulse.
- Knowledge of statistical theory and application of statistical methodologies in assay validations and process performance data analysis required.
- Ability to
- Perform tasks typically expected of a Biostatistician.
- Convey analytical thinking as well as business acumen and technical knowledge.
- Work effectively as part of a team and manage project(s) from a statistical perspective
- Determine appropriate statistical analysis methods and efficient experimental designs to address project objectives; detect and challenge methodological issues
- Pro-actively identify data issues and solutions and to interact with internal and external bodies (specialists and non-specialists) on complex statistical/methodological issues at the trial level or routine issues at the project level
- Write publications (as joint author)on relevant statistical topics
- Negotiate among multiple parties to find mutually reasonable outcomes
- Interact and negotiate with regulatory authorities on statistical issues at the project level
- Work with researchers and through communication determine the most effective and efficient design to address project objectives
- Lead others to successful outcomes without direct authority
- Expertise in particular scientific disciplines related to animal health or pharmaceutical/biological industry is highly desirable.
Who We Are\:
- 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.
- Willingness to travel domestically and internationally.
- This position will require individuals to be fully vaccinated against COVID-19 or have an approved medical or religious accommodation. Click here for more information on the vaccine mandate and COVID-19.
At Boehringer Ingelheim we create value through innovation with one clear goal\: to improve the lives of patients. We develop breakthrough therapies and innovative healthcare solutions in areas of unmet medical need for both humans and animals. As a family owned company we focus on long term performance. We are powered by 50.000 employees globally who nurture a diverse, collaborative and inclusive culture. Learning and development for all employees is key because your growth is our growth.
Want to learn more? Visit boehringer-ingelheim.com and join us in our effort to make more health.
Boehringer Ingelheim is an equal opportunity global employer who takes pride in maintaining a diverse and inclusive culture. We embrace diversity of perspectives and strive for an inclusive environment, which benefits our employees, patients and communities. All qualified applicants will receive consideration for employment without regard to a person's actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.
Web Reference : AJF/311168284-202
Posted Date : Sat, 02 Jul 2022
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