Connect Life Sciences
Director Biostatistics
Recruiting the people who drive science, delivering solutions that elevate clients
Job Description:
Serve as the lead statistician across multiple studies and projects spanning diverse therapeutic areas.
Contribute to the design of clinical trials, protocol development, and preparation of Clinical Study Reports (CSR).
Participate in study-related activities, offering statistical consultation, guidance, and input to cross‑functional teams.
Develop and/or review statistical deliverables for clinical trials, including Statistical Analysis Plans (SAP), integrated summaries of drug efficacy and safety, tables/figures/listings (TFLs), interim analysis plans, and other key documents.
Manage CRO statisticians and internal biostatistics staff, including junior statisticians, contract statisticians, and programming teams, to support biostatistics operations.
Represent the biostatistics function in clinical projects and studies, attending project and study team meetings as required.
Provide support for regulatory requests and meetings, maintaining close communication with functional management.
Deliver statistical expertise by identifying potential issues, recommending solutions, and engaging external experts when necessary.
Requirements:
Ph.D. in Biostatistics or Statistics.
Minimum of 4 years of experience in pharmaceutical clinical trials.
Strong knowledge of clinical trial methodology, regulatory requirements, and statistical principles.
Proficiency in SAS programming and R/S language.
Demonstrated ability to collaborate effectively in a dynamic, cross‑functional environment.
Excellent organizational, interpersonal, oral, and written communication skills.
Seniority level Director
Employment type Full-time
Job function Analyst and Project Management
Industries Pharmaceutical Manufacturing and Biotechnology Research
Location: Washington, DC
Salary: $105,000.00-$125,000.00
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Job Description:
Serve as the lead statistician across multiple studies and projects spanning diverse therapeutic areas.
Contribute to the design of clinical trials, protocol development, and preparation of Clinical Study Reports (CSR).
Participate in study-related activities, offering statistical consultation, guidance, and input to cross‑functional teams.
Develop and/or review statistical deliverables for clinical trials, including Statistical Analysis Plans (SAP), integrated summaries of drug efficacy and safety, tables/figures/listings (TFLs), interim analysis plans, and other key documents.
Manage CRO statisticians and internal biostatistics staff, including junior statisticians, contract statisticians, and programming teams, to support biostatistics operations.
Represent the biostatistics function in clinical projects and studies, attending project and study team meetings as required.
Provide support for regulatory requests and meetings, maintaining close communication with functional management.
Deliver statistical expertise by identifying potential issues, recommending solutions, and engaging external experts when necessary.
Requirements:
Ph.D. in Biostatistics or Statistics.
Minimum of 4 years of experience in pharmaceutical clinical trials.
Strong knowledge of clinical trial methodology, regulatory requirements, and statistical principles.
Proficiency in SAS programming and R/S language.
Demonstrated ability to collaborate effectively in a dynamic, cross‑functional environment.
Excellent organizational, interpersonal, oral, and written communication skills.
Seniority level Director
Employment type Full-time
Job function Analyst and Project Management
Industries Pharmaceutical Manufacturing and Biotechnology Research
Location: Washington, DC
Salary: $105,000.00-$125,000.00
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