Senior Manager, Biostatistics

Proclinical, in support of our client, are seeking an individual to fill the role of Senior Manager of Biostatistics, based in Cambridge, MA.

Responsibilities

• Contribute to clinical protocol development, including authoring of the section on statistical methods and reviewing/editing of all sections.
• Author statistical analysis plans for clinical trials, and author/edit mock tables, listings and figures.
• Review CRF designs to ensure data collection meet the study objectives and the requirements of statistical analyses.
• Specify randomization schedules and test their implementations.
• Work with external statistical programmers and data managers to generate tables, listings and figures.
• QC the key results of statistical programmers.
• Support ongoing safety review of the program/study teams and data monitoring committees.
• Perform ad hoc statistical analyses and basic SAS programming as needed.
• Contribute to the clinical study reports, including authoring of statistical sections and interpretation of the study results.
• Support regulatory submissions.
• Support the preparation of publications, including manuscripts, posters and oral presentations.
• Provide requirements and oversight to external statistical programmers, data managers and other relevant functions at CROs to ensure quality of deliverables.
• Participate in department and cross-functional meetings to optimize clinical study designs, endpoints, and analysis strategies.
• Provide statistical input on CDP, IDP, and registration plan.
• Provide analysis support for presentations and publications

Skills And Qualifications

• PhD in statistics or a related field and 3+ years of clinical trial experience in the pharmaceutical industry, or MS in statistics or equivalent with 5+ years of clinical trial experience in the pharmaceutical industry. Experience in oncology clinical research is strongly preferred.
• Knowledge of statistical methods that apply to Phase I-IV clinical trials.
• Knowledge of FDA and ICH regulations and guidelines.
• Interaction with regulatory authorities preferred.
• Experience investigating the relationships between biomarkers and clinical endpoints preferred.
• Relevant experience partnering with CROs.
• Proficient in statistical programming (SAS required, R preferred).
• Experience with trial design software; working knowledge of Spotfire preferred.
• Strong written, verbal, and interpersonal communication skills, with a focus on technical writing.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Brandon Zheng at (+1) 646-851-0869 or upload your resume on our website - www.Proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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