Director Biostatistics

Viatris; United States; Remote; USD 112,000 - 236,000; Full time

Job summary

An established industry player is seeking a Director of Biostatistics to lead impactful statistical projects in clinical research. This role involves overseeing the design and execution of studies, ensuring compliance with regulations, and collaborating with multiple departments to enhance patient health. The ideal candidate will possess a strong analytical background, excellent communication skills, and a proven ability to manage complex projects effectively. Join a forward-thinking organization that values innovation and teamwork, where your expertise will contribute to improving healthcare outcomes globally.

Benefits

Competitive Salaries

Inclusive Environment

Health Benefits

Remote Work Flexibility

Qualifications

• 5+ years of experience in Biostatistics in clinical research preferred.
• Strong knowledge of US CFR, SOPs, and Health Authority regulations.
• Ability to manage multiple projects effectively.

Responsibilities

• Oversee and approve protocols/reports for BE and PK studies.
• Interact with various departments regarding project planning.
• Supervise the training of the statistical team.

Skills

Analytical Skills

Problem-Solving Skills

Communication Skills

Statistical Analysis

Project Management

Technical Writing

Education

Bachelor's Degree

Master's Degree

PhD

Tools

Microsoft Office Suite

PK Statistical Program

Sigma Plot

Lotus Notes

Job description

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 Director 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. Supervises the design and execution of statistical projects, including data management.

• Interact with Product Development/Bioanalytical/Chemistry/Product Management Departments regarding project planning and data analysis. Reviews reports and other statistical documents from other departments as necessary, assisting in resolution of any directly related issues/discrepancies. Consults as needed on projects/products of business interest to Mylan.

• Assume responsibility in generating or reviewing answers prior to submitting to Health Authority questions. Recommend/approve and prepare data presentations and additional statistical information, as required.

• Assist in general day to day operations within the Statistical group of the PK/DM Department. Supervises the training of PK/DM statistical team.

• Assist in collection, management, quality assurance, statistical analysis, and reports of data generated by or on behalf of the PK/DM Department. Develops and updates policies, procedures and guidelines as needed. Reviews for comprehension relevant Standard Operational Procedures. (SOPs).

• Assist the statistical team to assure the quality, completeness and timeliness of projects communicating regularly with supervisors and colleagues on the teams' progress. Assists and works with other Directors in the management of staff resources to ensure that deadlines are met in the most efficient and cost-effective manner.

• Perform other duties as assigned, including duties and responsibilities assigned by executive management.

The minimum qualifications for this role are:

• Minimum of a Bachelor degree (or equivalent) and 5 years of experience. PhD with at least 8 years of experience or Master degree with at least 12 years of experience working in Biostatistics in clinical research fields 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 guidances.Knowledge of and understanding of all Company Standard Operating Procedures and policies; Good Clinical Practice and other associated global regulations, guidelines and industry standards as required.

• 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.

• Executes supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

• Ability to read and interpret comprehensive and intricate research documents.Ability to write scientific reports and technical correspondence.Ability to work with executives and communicate abstract concepts.Ability to present to a high level of the organization and groups outside of the organization.

• Ability to solve equations, apply technical mathematical concepts, and perform complex computations. Statistics background required.

• Ability to solve problems with complex variables through non-standardized solutions that require independent judgment and analysis.Ability to draw inferences and use deductive reasoning with no prescribed procedures to solve complex problems.

• Typically sitting at a desk or table. Intermittently sitting, standing, walking or stooping. May be required to stand; walk; stoop; bend; kneel; and climb steps. May require use of hands and use of arms.Sedentary lifting requirements. Periodic travel may be required.

• Normal office situation. Work closely with others.

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

Exact compensation may vary based on skills, experience, and location. The salary range for this position is $112,000.00 - $236,000.00.

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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