Reference #: R5649032 Mylan Pharmaceuticals Inc.

At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.

Viatris empowers people worldwide to live healthier at every stage of life.

We do so via:

Access - Providing high quality trusted medicines regardless of geography or circumstance;

Leadership - Advancing sustainable operations and innovative solutions to improve patient health; and

Partnership - Leveraging our collective expertise to connect people to products and services.

Every day, we rise to the challenge to make a difference and here's how the Senior Manager, Biostatistics role will make an impact:

Key responsibilities for this role include:

Oversee/Approve Protocols/Reports for BE and PK Studies ensuring that proper scientific methodology, statistical analysis, and data interpretation has occurred to arrive at scientifically justified conclusions.

Manage project plan, write SAP, perform data analysis.

Manage and provide oversight of issue/discrepancy resolution with Scientist Group and CRA group.

Provides consultation as needed on projects/products of business interest to Viatris.

Prepare and review responses prior to submitting to Health Authority questions or addressing Citizen's Petitions with respect to Pharmacokinetics.

Recommend/approve and prepare data presentations and additional statistical information, as required.

Assists in the supervision of the collection, management, quality assurance, statistical analysis, and reports of data generated by or on behalf of the GCPh Department.

Provide input in the development and review of SOPs, protocols, for departmental processes, procedures and best practices.

Responsibility for statistical outputs' accuracy and deliverables.

Perform other duties as assigned.

The minimum qualifications for this role are:

Minimum of a Bachelor's degree (or equivalent) and 4-6 years of experience. PhD with at least 8 years of experience or Master degree with at least 10 years of experience working in Biostatistics in clinical research fields is preferred.Pharmacokinetics or Industrial Pharmacy background, preferred. However, a combination of experience and/or education will be taken into consideration.

Must possess in-depth knowledge of US CFR, SOPs and Health Authority regulations and industry guidance.

Must possess strong analytical and complex problem solving skills. Must possess strong writing, communication, and presentation skills. Must be able to manage multiple projects, have strong computer skills and a working knowledge of Microsoft Office Suite, PK Statistical Program, Sigma Plot, and Lotus Notes.

Position functions semi-autonomously. Position may directly supervise employees. Carry out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities may include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems

Ability to read and interpret complex business and/or technical documents. Ability to write comprehensive reports and detailed business correspondence. Ability to work with managers or directors and communicate ambiguous concepts.Ability to present to groups across the organization.

Ability to perform computations such as percentages, ratios, and rates. Statistics background

Ability to solve problems with a variety of concrete variables through semi-standardized solutions that require some ingenuity and analysis.Ability to draw inferences and follow prescribed and detailed procedures to solve moderately complex problems.

Proficiency in speaking, comprehending, reading and writing English is required.

Exact compensation may vary based on skills, experience, and location. T e salary range for this position is $95,000.00 - $193,000.00 USD.

At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.

Viatris is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, gender expression, disability, or protected veteran status, or any other characteristic protected by local, state, or federal laws, rules, or regulations.

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Mylan offers competitive salary, excellent benefits and an environment conducive to professional growth and advancement. All qualified applicants will receive consideration for employment without regard to their disability or protected veteran status. Mylan is an Equal Opportunity Employer, Minorities/Female/Disabled/Veteran.Â