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Contact: Neisha Camacho/Terra Parsons - teamnt@penfieldsearch.com
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Job Overview

We are seeking a highly skilled and motivated Biostatistician to lead our biometrics function across multiple studies in one of the late-phase programs for cardiovascular drug development. As the AD Biostatistician, you will be the study lead, representing biometrics in cross functional team meetings. You will be responsible for discussing and shaping the clinical development plan, study design, endpoint selection, statistical analysis plan, and regulatory submission and publication strategy to support pursuant of precision medicine. This role involves overseeing CROs and collaborating with cross-functional teams to deliver high-quality analysis outputs and interpret results.

Essential Duties And Responsibilities

• Collaborate with clinical, regulatory, medical affairs, and other teams to ensure cohesive and integrated project strategies.
• Contribute to clinical protocol development and study reports, including authoring of the Statistics section and reviewing of other sections by applying statistical principles.
• Author or review statistical analysis plans for clinical trials and for integrated summaries of safety/effectiveness (ISS/ISE), and author or oversee the development of shells for tables, figures and listings.
• Review case report form (CRF) designs to ensure data collection meet the requirements of statistical analyses.
• Provide statistical input to data monitoring committee (DMC) charters.
• Oversee the CROs or internal teams to deliver high-quality and timely analysis outputs and interpret the results.
• Manage statistical activities in support of NDA/MAA or other regulatory submissions.
• Address statistical questions/comments from FDA and other regulatory agencies.
• Support and contribute to the preparation of publications, including manuscripts, posters and oral presentations.
• Contribute or lead standardization and process improvement efforts for Biostatistics and contributes to cross-functional process improvement efforts.
• Provide guidance and oversight to ensure compliance with regulatory standards and best practices.
• Mentor junior statisticians.

Qualifications And Preferred Skills

• PhD in Statistics, Biostatistics, or a related scientific field with 7+ years of experience, or MS with 10+ years of experience in clinical trials, drug development, the pharmaceutical industry, or healthcare.
• Expertise in applying knowledge of general and cutting edge statistical / clinical trials methodology to solve complex statistical problems in the clinical development area and ensure alignment with regulatory agencies and industry standards.
• Knowledgeable of machine learning approaches for classification and predictive modeling.
• Excellent communication and presentation skills, with the ability to convey complex statistical concepts to non-statisticians.
• Strong knowledge and hands-on experience of statistical software (SAS, R or Python) and proficiency in implementation of advanced analytical methods especially for data visualization.
• Experience in managing CROs and collaborating with cross-functional teams.
• Experience with NDAs, and MAA’s is highly desired.
• Experience with cardiovascular drug development and digital health data or real-world data is preferred.
• Demonstrated ability to work independently and as part of a team in a fast-paced, dynamic environment.