Statistical Innovator - Pharmaceutical Industry

Transforming Clinical Development through Statistical Innovation

We're seeking an accomplished Principal Biostatistician to lead Phase II-III studies with expertise in advanced methods and machine learning algorithms. This key role involves collaborating closely with clients to drive projects forward, leveraging passion for biostatistics to empower patients and healthcare professionals.

Key Responsibilities

• Providing Strategic Input : Contributing statistical expertise to study protocols, CRFs, and data management plans; writing statistical analysis plans; reviewing or creating analysis dataset specifications; and performing statistical analyses.
• Authoring Study Documents : Incorporating estimand frameworks into study documents and creating specifications for time-to-event and longitudinal analysis.
• Reviewing and Contributing to Study Reports : Reviewing clinical and statistical sections of regulatory submission dossiers, leading electronic submissions to regulatory authorities, and participating in meetings with regulatory authorities.
• Project Management : Managing biostatisticians and statistical programmers regarding statistical strategy, deliverables, and processes when serving as Lead Biostatistician for a project.
• Innovative Methodologies : Adapting and developing innovative statistical methodologies by identifying optimal approaches and techniques suitable for each project.

Candidates should possess a PhD in statistics or a master's degree in statistics or a related subject, along with clinical trial experience. Relevant experience in statistical or biostatistical analysis supporting clinical trial operations for the pharma / biotech industry is preferred. We offer consistent training, development, and support to enable success in this role.

Required Skills and Qualifications :

Candidates should have a strong background in statistics, with experience in clinical trials. A PhD in statistics or a master's degree in statistics or a related field is required. Strong analytical skills, excellent communication skills, and the ability to work effectively in a team environment are essential.

Benefits :

We offer a competitive salary, comprehensive benefits package, and opportunities for professional growth and development. Our company is committed to providing a supportive and inclusive work environment that enables our employees to thrive.

Others :

Our company is dedicated to improving patient outcomes through innovative statistical solutions. As a Principal Biostatistician, you will play a critical role in driving this mission forward.

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