Associate Director, Biostatistics and Programming
Quantime World PVT LTD · Thiruvananthapuram +1 more, India
Free account: apply link, HR contact and an AI-written cold email
Quantime World PVT LTD · Thiruvananthapuram +1 more, India
Free account: apply link, HR contact and an AI-written cold email
Join a global Contract Resource Organization (CRO) where innovation meets purpose. At Worldwide Clinical Trials, we're driven by a shared commitment to improving lives through high-quality clinical research. Our teams are empowered to think creatively, take ownership, and deliver meaningful work that helps bring life-changing therapies to patients around the world. With more than 4,000 professionals across the globe, we foster a collaborative and inclusive environment where diverse perspectives are valued, growth is encouraged, and every contribution makes an impact. Whether you're building your career or bringing years of experience, you'll have the opportunity to learn, grow, and help shape the future of clinical research. SUMMARY: The Associate Director, Biostatistics and Programming, is a key member of the Biostatistics and Statistical Programming department. The provide daily supervision of Biostatistics and Statistical Programming operations and personnel to ensure the achievement of departmental goals and levels. This role will plan, analyze, and summarize the results of individual clinical studies or groups of studies (integrated summaries)in accordance with Worldwide Standard Operating Procedures (SOPs) or study specific guidelines. They will manage and mentor biostatistics and programming staff, lead department initiatives, report out to senior leadership, participate in business development activities and assist functional leads in the financial plus operational oversight of their projects. RESPONSIBILITIES: Tasks may include but are not limited to: Provide oversight on multiple clinical research projects. Support Leads in low/moderate/high complexity studies in various phases of development. Effectively manage broad-based projects such as NDA submissions or complex, multi-protocol programs, potentially coordinating activities across multiple locations. Provide technical expertise, in conjunction with internal and external team members, to design, implement, analyze, report, and validate clinical trials. Collaborates with internal and external project team personnel, as needed, to meet project deliverables and timelines and ensure accurate, statistically valid deliverables. Ensure adequate staffing of all project teams and help coordinate resources across the Department. Represent department and company in a multi-disciplinary setting, including project team meetings, client meetings/presentations, and bid defense meetings. Provide statistical and programming advice/recommendations regarding clinical study design/study endpoints, sample size requirements, statistical methodology for the study protocol and clinical study report, programming strategy and document review/approval. Oversee all biostatistical and statistical programming activities, including statistical analysis plan development, database specification, reporting specification, statistical programming analysis, and statistical summary/report writing.
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