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Additionally, the role involves representing the organization in interactions with regulatory agencies, fostering a culture of excellence and continuous improvement within the Global Biometrics and Data Sciences, and serving as a thought leader in the field of real-world evidence.
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Master's degree in statistics or biostatistics with 8+ years of biopharmaceutical statistics experience with specific experience in late stage drug development, including phase IIb, phase III, and submissions in the pharmaceutical industry.
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This is a unique opportunity for an experienced biostatistician/ stat programmer people leader to join the Scientific Insights & Analytics group (Biometrics & Scientific Communications) in the Surgical Structural Heart Valve business unit to support various global medical and clinical activities.
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Establish and maintain effective communication and collaboration with functional area peers including Pharmacovigilance, Drug Supply, Quality Assurance, Regulatory Affairs, Legal, Medical Writing, Biostatistics and Data Management to meet program objectives and support achievement of goals.
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Masters in Statistics or Biostatistics Plus 8+ years of previous related experience in analytical experience with clinical trials /clinical research. Director, Biostatistics Operations (Scientific Insights & Analytics) - Surgical Structural Heart.
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Providing guidance on process improvement projects within biostatistics and cross-functional areas. Managing and oversee the work of Biostatistics Operations team, including statistical methods and programming.
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Join Cytel’s enthusiastic and collaborative Biometrics team by contributing to the overall success of our novel gene therapy development programs. MS in biostatistics or a related field, with 5-8 years of experience in the pharmaceutical industry, or BS in biostatistics or a related field, with 7-10 years of experience in the pharmaceutical industry.
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Reporting to the VP of Biometrics, you will support both early and late phase oncology products, interact with regulatory officials on all statistical related matters, oversee development plans, and provide strategies for clinical study design, endpoint selection, sample size calculations, statistical analysis plans (SAP) and more.
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Experience in managing a Biostatistics or Biometrics team and overall resource planning. Oversees collaboration with internal and external (e.g., CRO) team members to coordinate the planning and execution of Biometrics or Biostatistics deliverables from internal and external teams (e.g., CRO) that meet their objectives while complying with regulations and quality.
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The Senior Director of Real-World Evidence Biostatistics plays a pivotal role in leading and overseeing the strategic direction and execution of statistical and real-world evidence initiatives within the organization.
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Director, Biostatistics Operations (Scientific Insights & Analytics) - Surgical Structural HeartDedicated to innovation, our Surgical business unit is focused on identifying and solving critical, unmet needs in cardiac surgery.
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PhD or MS (12+ years experience) in statistics or biostatistics or related scientific field with clinical trials, drug development, pharmaceutical industry or healthcare experience. Represent the organization at conferences, forums, and industry events to showcase expertise and thought leadership in biostatistics and real-world data.
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This is a unique opportunity for an experienced biostatistician leader to join Scientific Insights & Analytics group (Biometrics & Scientific Communications) in the Surgical Structural Heart Valve (SURG) business unit to support various global medical and clinical activities.
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Head of Biometrics and Data Integrity, as the experienced biostatistician will oversee and guide the statistical work across Curium early and late phase clinical development, HEOR/RWE and medical affairs studies which includes biostatistics and clinical programming work performed by external vendors.
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Ph. D. in statistics (or closely related field e.g. medical statistics, biometrics, medical informatics, biopharmaceutical statistics) with 2 years biopharmaceutical industry experience as a biostatistician or a Master's degree in a relevant statistics field and 4 years industry experience (as a biostatistician) in Biotech, Pharma, Regulatory agencies, or Clinical Research Organizations (title commensurate with experience.
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