SDC is a team of diversified professionals who deliver exceptional Biometric Services, Consulting, and Technology Solutions to pharmaceutical, biologic, and medical device / diagnostic companies. Since 2005 our purpose has been to partner with sponsors to provide high-quality and experienced team members to develop great medicines that save lives and cure diseases in the most efficient manner possible. Our global team operates as a valued partner to our clients by fulfilling their needs as our own and delivering exceptional results. We are a specialty CRO in that we provide scalable service offerings, focused services area specialists, efficient project timelines, optimal technology solutions, and proven success and experience. Our commitment to our clients is the same commitment to our employees. By offering strong benefits including competitive pay, generous time off, attainable career advances, positive work / life balance, and 401k matching (US), we are able to attract some of the most talented people in the industry. Why SDC We are committed to developing our employees. We recognize achievements, provide growth opportunities and career advancement, offer a flexible work schedule, engaging work culture and employee benefits. We are passionate about our company culture. Our recognition program is directly tied to our core values of Energy, Integrity, Engagement, Innovation, Ownership, and Commitment. We strive to provide a place of belonging to our employees with fun and engaging activities from SDC’s culture club. We are constantly growing and innovating to support our client and employee needs. Global in nature, we bring diverse perspectives enabling our growth in this ever-evolving industry. With a proven track record, SDC has been successfully executing client clinical programs since 2005. Take a look at how you can join our team! The Senior Biostatistician serves as lead biostatistician on clinical studies. Maintains the statistical integrity of clinical trials analyzed by SDC. Actively participates in writing statistical sections of protocols, preparing statistical analysis plans, preparing data deliverables for clinical study reports, interpreting analysis results, writing statistical sections of clinical study reports, and participating in meetings with drug regulatory agencies as required. Act as the lead statistician on clinical research projects Provide statistical expertise for study design of clinical trial protocols Write statistical methods section of the study protocol, as needed Write statistical analysis plans ensuring appropriate regulatory requirements and study objectives defined in the study protocol are followed Review CRFs to ensure consistency with protocol and adequacy in collecting data to meet objectives and statistical analyses defined in the protocol Program summary tables, data listings and graphical representations of clinical trials data Ensure proper execution of all analyses defined in the statistical analysis plan as well as any post-hoc analyses and relevant exploratory analyses of clinical trial data Prepare key sections of clinical study reports and various regulatory documents Perform statistical QC of final clinical study reports Provide statistical support to answer questions from external clients (such as FDA, Investigators) Contribute to the development of standard operating procedures for clinical trials Represent statistical operations department at regulatory meetings, sponsor meetings, and any other multifunctional meetings, as needed Manage biostatistics timelines, budgets, and client expectations Create a job alert for this search Senior Biostatistician • Durham, North Carolina, United States #J-18808-Ljbffr SDC (Statistics & Data Corporation)
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