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At EMD Serono, Inc. our strength is our people!About the CompanyEMD Serono, Inc., an affiliate of Merck KGaA, Darmstadt, Germany, is a leader in the US biopharmaceutical arena, integrating cutting-edge science with unparalleled patient support systems to improve people's lives. The company has strong market positions in neurodegenerative diseases, MS and endocrinology. EMD Serono is also a leader in fertility treatments. With a clear focus on the patient and a leadership presence in the biopharmaceutical industry, EMD Serono's US footprint continues to grow, with more than 1000 employees around the country and fully integrated commercial, clinical and research operations in the company's home state of Massachusetts.
Description
- Function as a project biostatistician coordinating statistical aspects across clinical trials within a specific project in a therapeutic area
- With limited direction, provide statistical input for statistically complex protocol development
- With limited direction, write statistical analysis plans and perform statistical analyses for statistically complex clinical trials
- With limited direction, write statistical analysis plans and perform statistical analyses for safety and efficacy summaries for regulatory submissions
- Independently provide statistical input for statistically routine protocol development
- Independently write statistical analysis plans and perform statistical analyses for statistically routine clinical trials
- Participate in departmental standardization efforts
- Provide support towards statistical research
Key Tasks & Responsibilities- Participate on clinical development teams
- Provide statistical input into clinical development plans
- With limited direction, participate in the development of statistical standards for clinical development programs
- Review statistical analysis plans written by other statisticians on the project
- Review statistical analysis results produced by other statisticians on the project
- Review statistical methods sections and the interpretation of results written by other statisticians on the project
- Provide statistical support for manuscripts and review manuscripts for accurate statistical interpretation
Functional Roles and Responsibilities:- With limited direction, provide statistical input for protocol/CRF development (e.g., trial design; sample size estimation for the most efficient and practical design; patient randomization; accurate, logical, clear, concise and thorough evaluation of results section; effective CRF specifications to collect data specified the protocol)
- With limited direction, write statistical analysis plans for clinical trials as well as for integrated safety and efficacy summaries. Analysis plans written include the most appropriate statistical methodology and data presentations.
- With limited direction, analyze clinical trials
- With limited direction, write accurate, logical, clear, concise, thorough and objective statistical methods sections for clinical trial reports
- Review and co-author clinical trial reports ensuring the accuracy of the statistical interpretation
- Understand and follow all Global Biostatistics WIs/SOP as well as any other relevant WIs/SOPs. Provide input into all newly developed departmental quality documents
- Provide input into general standardization efforts (e.g., CRFs, query checks, statistical methodology, standard statistical programs, data presentations)
- With direction, interact with regulatory agencies regarding statistical issues
- With direction, develop responses to regulatory agency requests that maintain perspective and are within the appropriate context
- Participate effectively on clinical trial teams
- With direction, provide solutions for complex issues presenting alternatives and identifying the best solution
- With limited direction, communicate routine and complex statistical concepts and results to non-statistical internal and external colleagues in a clear, concise, focused and articulate manner
- With limited direction, function as the statistical primary contact with CROs for studies that are outsourced, and ensure the accuracy and timeliness of the CROs analysis alerting management to any unforeseen circumstances
- Produce assigned work within the timelines provided ensuring deadlines are met
Education/Languages- Ph.D. or MS in statistics, biostatistics or related discipline
- Fluent in English (French or German is a plus)
Professional Skills & Experience- Several years experience in the Pharmaceutical/Biotechnology industry
- Working SAS knowledge and proficient in SAS/Stat
- Knowledge of ICH Statistical and Clinical Report Guidelines
- Familiarization with relevant therapeutic areas
Personal Skills & Competencies- Ability to work in a matrix organization
- Ability to work with multi-disciplinary groups
- Strong communication, negotiation and issue resolution skills
- Balance concurrent tasks and responsibilities
Click the link below and open the door to the future by submitting your resume today!EMD Serono 0901059