Senior Manager, Biostats, Sickle Cell Disease
ProClinical, in support of our client, are seeking an individual to fill the role of Senior Manager, Biostatistics, based in Cambridge, MA. The successful candidate will be responsible for overseeing statistical activities for multiple clinical studies, participating study designs and protocol development, ensuring compliance with SOPs to produce quality and timely deliverables.
- Serve as a lead statistician and manage statistical efforts for multiple clinical studies.
- Contribute to clinical protocol development.
- Author statistical analysis plans for studies and/or ISS/ISEs, and author/edit shells for tables, figures and listings.
- Review CRF designs to ensure data collection meet the study objectives and requirements of statistical analyses.
- Provide statistical input to data monitoring committee charters, project management plan, etc.
- Work with statistical programmers or CROs to generate tables, figures and listings.
- Contribute to clinical study reports.
- Support the preparation of publications, including manuscripts, posters and oral presentations.
- Provide oversight of CROs for outsourced statistical activities and QC key results generated by CROs.
Skills And Qualifications
- PhD in statistics or a related field and 3+ years of relevant clinical trial experience OR MS in statistics or equivalent with 6+ years of relevant clinical trial experience.
- Knowledge of statistical methods for clinical trials.
- Knowledge of FDA, EMA and ICH regulations and guidelines.
- Proficient in statistical programming - SAS is required, R preferred.
- Experience with trial design software.
- Good communication skills and ability to work with cross-functional study teams
- Ability to multitask in an extremely fast-paced environment with changing priorities.
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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