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Principal Biostatistician Team Leader

Boehringer Ingelheim

This is a Full-time position in Athens, GA posted April 29, 2021.

Description:

Description:

 

Provides significantstatistical expertise and strategic planning, influence, and leadership forclinical studies and other initiatives within the global R&DOrganization.  

 

The Senior PrincipalBiostatistician TL is a Subject Matter Expert in Biostatistics, providing (orensuring within hiTheyr area) full statistical support for regional and globalclinical development projects, marketed products and publications to achieve  business objectives.  They may influence industry and regulatorypolicy in relation to statistical methodologies, designs, and analyses thatprovide support of approvals, and represents the company before regulatory agenciesand other organizations in defense of statistical methodologies, designs, andanalyses related to our products. 

 

As Team Leader theSenior Principal Biostatistician TL manages a team of Biostatistics personnel,ensuring attraction, development and retention of qualified talent, appropriatedistribution of workload to meet business objectives, and continued successionin key positions.

 

As an employee ofBoehringer Ingelheim, you will actively contribute to the discovery,development and delivery of our products to our patients and customers.

Ourglobal presence provides opportunity for all employees to collaborateinternationally, offering visibility and opportunity to directly contribute tothe companies’ success.

We realize that our strength and competitive advantagelie with our people.

We support our employees in a number of ways to foster ahealthy working environment, meaningful work, diversity and inclusion,mobility, networking and work-life balance.

Our competitive compensation andbenefit programs reflect Boehringer Ingelheim’s high regard for our employees.

 

Duties &Responsibilities:

Lead a team of Biostatisticians, and apply ahigh degree of statistical expertise to advance and influence clinical programsfrom a statistical perspective.

Mentor and develop members of the group.  Attract new members into the group.

Ensuretraining for team members.

Ensure understanding within group ofstrategies, accountabilities; have processes in place to ensure timeliness,compliance and quality of statistical and programming deliverables according toproject plans for all studies and projects.

Serve as the primary point of contact forcontractors on Biostatistics matters and handle contract details.

Perform all responsibilities of aprincipal/project Biostatistician for multiple projects, especially forcritical, complex clinical trials or trials in areas without previous BIexpertise.

Leverage expertise and relationships tofacilitate a strong negotiation position on project
– and statistics-related issues.  Engage and collaborate with internationalcolleagues to promote international harmonization.

Take active or leadershiproles in internal/external working groups.

Keep abreast of industry development.

Promotevisibility outside of functional area and effectively interact scientificallywith Key Opinion Leaders in relevant fields. Effectively liaise internally with cross-functional stakeholders tocommunicate and align expectations. Apply broad knowledge of statistics and current literature to influenceindustry and regulatory agencies in the application of new methodologies.  Recognize opportunities across the globalR&D organization as well as outside sources for scientific technologiesthat may represent new trial designs, methods of analysis, processes,platforms, or products for the company.

Contribute to departmental administration;execute financial responsibility with regard to departmental budget.  Ensure that work performed is conducted in asafe and compliant manner.

Maintain proper records in accordance with policies.Collaborate with management, team and stakeholders  to set and achieve project goals. 

Requirements:

Masters degree in Statistics/Biostatisticsfrom an accredited institution.

Doctoral degree preferred.

With a Masters degree, 13 years of industry orrelevant experience; with a Doctoral degree, 10 years of industry or relevantexperience.

Experience in the pharmaceutical, animalhealth, or agricultural science industry is required and should include clinicaltrial design and analysis.

Software proficiency: SAS, R, MS Officeapplications.

Demonstrated industry-leading knowledge ofstatistical methodology and its application to clinical trials plus solidunderstanding of applicable regulations governing the Animal Health Industry.

The individual should play a LEADING role inthe organization relative to Biostatistics, drug/vaccine development,regulatory knowledge and project management, exhibiting:

Knowledge of thepharmaceutical/biological life cycle process.

Analyticalthinking as well as business and technical knowledge.

Negotiate amongmultiple parties to find mutually reasonable outcomes; outstandingcommunication skills overall.

Determineappropriate statistical analysis methods and efficient experimental designs toaddress project objectives; detect and challenge methodological issues; performtasks typically expected of a trial Biostatistician.

Pro-activelyidentify data issues and solutions and to interact