Director, Biostatistics - PK/PD

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Overview

BeiGene is actively seeking a Director of Biostatistics specialized in pharmacokinetics (PK) and pharmacodynamics (PD) as part of its commitment to improving patient outcomes. The company emphasizes rapid growth and exciting challenges for experienced professionals who are motivated and collaborate effectively. This role is crucial in leading statistical efforts across various phases of clinical development, which is directly tied to the company's mission in oncology and other therapeutic areas.

Key Responsibilities

The Director of Biostatistics will be responsible for:

• Providing strategic biostatistical leadership across all PK/PD studies, ensuring high standards of scientific rigor and execution quality.
• Collaborating with various departments, namely Clinical Pharmacology, to design studies that evaluate pharmacokinetics, absorption, distribution, metabolism, and interactions of drugs.
• Developing statistical analysis plans (SAPs) for various PK/PD endpoints.
• Conducting exploratory analyses that will inform both clinical and regulatory strategies, including covariate modeling and data visualization.
• Ensuring the delivery of statistical components for regulatory submissions such as INDs, NDAs, and BLAs in a timely and compliant manner.
• Effectively communicating complex statistical concepts to different stakeholders, including technical teams and senior leadership.
• Partnering with internal teams and external partners (like CROs) to streamline study designs and report their findings.
• Continuously improving standard operating procedures (SOPs) for data analysis to ensure best practices are consistently applied across projects.
• Mentoring and developing junior statisticians to foster a culture of excellence and professional growth.

Qualifications

To apply for the Director of Biostatistics position, candidates should meet the following criteria:

• A Master’s Degree with at least 7 years of relevant experience, or a Ph.D. with at least 5 years of experience in the field.
• Demonstrated expertise in PK modeling, including non-compartmental and population PK analysis.
• Experience within oncology, immunology, or inflammation areas is highly preferred.
• Proficient in SAS programming and understanding of data management principles.
• Strong collaboration skills with the ability to work with cross-functional teams.
• Excellent verbal and written communication skills to convey complex information succinctly.

Salary and Benefits

The salary range for this position is $180,200 to $240,200 annually. BeiGene values fair compensation practices reflecting the candidate’s skills, experience, and other factors specific to each role. The company provides a comprehensive benefits package that includes:

• Medical, Dental, and Vision insurance
• Flexible Spending Accounts (FSA) / Health Savings Accounts (HSA)
• 401(k) plans
• Life Insurance
• Paid Time Off (PTO)
• Wellness programs
• Opportunities for stock ownership through discretionary equity awards and an Employee Stock Purchase Plan.

Company Culture and Commitment

BeiGene prides itself on being an equal opportunity employer. The company does not discriminate on various grounds such as race, religion, gender identity, or disability, and emphasizes hiring based on qualifications and merit. In addition to maintaining an inclusive work environment, BeiGene is committed to updating their policies and practices to ensure a supportive experience for all employees.

Job Location and Application Process

This remote position is based in the United States. Interested candidates are encouraged to submit their applications through BeiGene’s official channels, where they can find more specific details about the role and its expectations. The hiring team will discuss further details regarding the salary range and benefits associated with preferred locations during the hiring process.

Conclusion

In summary, the Director of Biostatistics role at BeiGene offers a compelling opportunity for professionals who are passionate about driving statistical innovation and clinical insights. This position is ideal for those with a strong background in biostatistics, especially in PK/PD studies, who seek to make significant contributions to improving the understanding of drug efficacy and safety.

This job offer was originally published on himalayas.app