Vanda Pharmaceuticals Inc.
Associate Director/Director, Biostatistics
Vanda Pharmaceuticals Inc., Washington, District of Columbia, us, 20022
Primary Responsibilities
Working as the leading statistician on multiple studies/projects across different therapeutic areas. Contributing to clinical trial design, protocol development, and Clinical Study Reports (CSR).
Participating in study-related activities and providing statistical consultation, input, and guidance to cross-functional groups.
Developing and/or reviewing statistical documents or deliverables for clinical trials, including Statistical Analysis Plans (SAP), integrated summaries of drug efficacy and safety, tables, figures, listings (TFLs), interim analysis plans, and others.
Managing CRO statisticians and internal biostatistics teams, including junior statisticians, contract statisticians, and programming teams, in support of biostatistics operational activities.
Representing the biostatistics function in clinical projects and studies, attending project and study team meetings as needed, and supporting activities related to regulatory requests and meetings. Close communication with the functional manager is expected.
Providing statistical expertise by identifying potential issues, offering recommendations, and involving external statistical experts for relevant issues as needed.
Requirements
Ph.D. in Biostatistics or Statistics.
At least 4 years of pharmaceutical clinical trial experience.
In-depth knowledge of clinical trial methodology, regulatory requirements, and statistics.
Comprehensive experience with SAS programming and R/S language.
Ability to effectively collaborate in a dynamic environment.
Excellent practical, organizational, interpersonal, oral, and written communication skills.
Additional
We are open to providing relocation for this position.
The total compensation package includes incentive compensation and benefits such as health insurance, unlimited paid time off, parental leave, a 401k matching program, and other employee benefits.
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, gender identity, sexual orientation, protected veteran status, or any other characteristic protected by law.
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Working as the leading statistician on multiple studies/projects across different therapeutic areas. Contributing to clinical trial design, protocol development, and Clinical Study Reports (CSR).
Participating in study-related activities and providing statistical consultation, input, and guidance to cross-functional groups.
Developing and/or reviewing statistical documents or deliverables for clinical trials, including Statistical Analysis Plans (SAP), integrated summaries of drug efficacy and safety, tables, figures, listings (TFLs), interim analysis plans, and others.
Managing CRO statisticians and internal biostatistics teams, including junior statisticians, contract statisticians, and programming teams, in support of biostatistics operational activities.
Representing the biostatistics function in clinical projects and studies, attending project and study team meetings as needed, and supporting activities related to regulatory requests and meetings. Close communication with the functional manager is expected.
Providing statistical expertise by identifying potential issues, offering recommendations, and involving external statistical experts for relevant issues as needed.
Requirements
Ph.D. in Biostatistics or Statistics.
At least 4 years of pharmaceutical clinical trial experience.
In-depth knowledge of clinical trial methodology, regulatory requirements, and statistics.
Comprehensive experience with SAS programming and R/S language.
Ability to effectively collaborate in a dynamic environment.
Excellent practical, organizational, interpersonal, oral, and written communication skills.
Additional
We are open to providing relocation for this position.
The total compensation package includes incentive compensation and benefits such as health insurance, unlimited paid time off, parental leave, a 401k matching program, and other employee benefits.
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, gender identity, sexual orientation, protected veteran status, or any other characteristic protected by law.
#J-18808-Ljbffr