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Form of workJob Description
The Contract Senior Biostatistician should have a keen interest in clinical trials, strong programming (R) skills, and a solid foundation in statistical theory to support pre-clinical/clinical development. This individual will provide statistical input for design, implementation, and analysis of clinical studies as well as associated biomarker development. In addition, the individual will apply a wide range of cutting-edge data analysis tools and methodology towards both publicly available as well as client generated data to provide Client insights and data driven hypotheses. The candidate will have the opportunity to help shape how this client consumes and understands its data; develop an in-depth understanding of drug development in a fast-moving biotech company; identify and solve interesting and relevant problems; and contribute to improving and advancing our understanding of neurodegeneration.
Responsibilities:
Provide statistical expertise and contribute strategically to projects in all lifecycles of drug development. This may include participation in clinical development teams as the biometrics representative.
Ensure statistical integrity of analyses and reporting deliverables, including guidance on statistical methodology, optimization of experimental design, sample size estimation, development planning.
Develop and conduct exploratory analyses on both in-house and external data to gain useful insights.
Consult on programming, modeling, visualization, and statistical methodologies.
Vendor selection and oversight.
Represent client at regulatory interactions (FDA/EMA meetings) and Advisory Committee meetings.
Requirements:
MS or Ph.D. in Statistics, Biostatistics, or similar quantitative field and 5+ years of experience with clinical trial studies, including early-phase (I-II) development.
Substantive knowledge in general statistical methodology with expertise in at least one specialized area of statistics.
Strong programming skills in R.
Working knowledge of a document-layout language. (Markdown, LaTeX, HTML, etc)
Working knowledge of GitHub or similar version controlled sharing platform.
Strong analytical and problem solving skills; expert collaboration and communication skills.
Highly independent, curious and creative, can do attitude, and embraces continuous improvement culture
Ability and interest to work cross functionally with basic science research and clinical colleagues
Responsibilities:
Provide statistical expertise and contribute strategically to projects in all lifecycles of drug development. This may include participation in clinical development teams as the biometrics representative.
Ensure statistical integrity of analyses and reporting deliverables, including guidance on statistical methodology, optimization of experimental design, sample size estimation, development planning.
Develop and conduct exploratory analyses on both in-house and external data to gain useful insights.
Consult on programming, modeling, visualization, and statistical methodologies.
Vendor selection and oversight.
Represent client at regulatory interactions (FDA/EMA meetings) and Advisory Committee meetings.
Requirements:
MS or Ph.D. in Statistics, Biostatistics, or similar quantitative field and 5+ years of experience with clinical trial studies, including early-phase (I-II) development.
Substantive knowledge in general statistical methodology with expertise in at least one specialized area of statistics.
Strong programming skills in R.
Working knowledge of a document-layout language. (Markdown, LaTeX, HTML, etc)
Working knowledge of GitHub or similar version controlled sharing platform.
Strong analytical and problem solving skills; expert collaboration and communication skills.
Highly independent, curious and creative, can do attitude, and embraces continuous improvement culture
Ability and interest to work cross functionally with basic science research and clinical colleagues
