Vice-President, Biostatistics and Data Management

Overview

The Vice President, Biostatistics and Data Management will help continue advancement of our clinical pipeline in immunotherapy and will actively support Celldex's clinical development programs. The successful candidate will be a key leader in the organization, responsible for the strategic planning, oversight and delivery of the biostatistics, data management, and statistical programming functions across the clinical development program. The Vice President will collaborate with other leaders and groups on development approach, will recommend appropriate strategies to clinical leadership, and will be responsible for ensuring statistical design, data management, analysis and statistical reporting across programs are high quality and meet the requirements of global health authorities.

Responsibilities

• Lead and manage biostatistics and data management efforts for clinical development programs.
• Plan, execute and oversee the design, data management, analysis and reporting of clinical trial data, ensuring high quality, regulatory compliance and timeliness.
• Provide high level of statistical input to efficiently support complicated study designs.
• Prepare statistical consideration section and provide input into other protocol sections.
• Oversee development of data standards and data collection strategies to deliver high quality data
• Close collaboration with CRO statisticians to ensure robust statistical methodologies and compliance with regulatory standards in statistical analysis plans (SAPs) and analysis.
• Review, synthesize and interpret analysis results, and provide statistical input for preparation of required documents including final study reports, publications, and regulatory submissions.

• Lead and manage internal and external resources, providing guidance and mentorship; may participate in activities, including programming, as necessary to accomplish objectives.
• Develop and implement biostatistical and data management strategies for clinical trials
• Support regulatory requests and potential filings and support potential partnering requests.
• Stay abreast of data management and statistical developments, methods, and technologies related to the Biotech/Pharmaceutical industry.
• Make strategic and tactical recommendations to provide and ensure a competitive advantage to the company.

Qualifications

• PhD in biostatistics, statistics, or related field required
• 10+ years of experience as a Biostatistician and 5+ years of experience in Data Management
• 10+ years of experience working in the Pharma/Biotech industry.
• Prior experience in a leadership or management role
• Proven track record of leadership within statistics in clinical drug development, especially in immune-based disorders (allergy, immunology), in a Pharmaceutical/Biotech/CRO setting.
• Demonstrate proficiency in the design, data management, analysis and reporting of clinical trials Phase I-III.
• Strong knowledge of clinical trial design concepts, clinical drug development process, data management, statistical methodologies and data management and statistical regulatory requirements and guidances including ICH and CDISC.
• Extensive experience with data management tools, clinical data standards, programming and statistical computing software (e.g. SAS).
• Experience with collection and analysis of patient reported outcome data.
• Experience as statistical representative with regulatory submissions and interactions with health authorities.
• Experience with integrated summaries of safety and efficacy (ISS and ISE)
• Experience in managing, developing, and motivating professionals, including external consultants and contract research organizations
• Excellent interpersonal, communication, writing and organizational skills.
• Demonstrated ability to work effectively in a collaborative, fast paced team environment.
• Strong problem-solving and decision-making abilities
• A high level of attention to detail and accuracy

Celldex is proud to be an equal opportunity employer that strives to foster a culture of diversity, equity, and inclusion. We are committed to promoting a diverse environment through development, recruiting and community outreach.

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