Current jobs related to Biostatistician I - Wilmington - Catalyst Clinical Research LLC

Job DescriptionJob DescriptionPosition Summary:  As a Biostatistician I you will be a key member of the Development Operations, Biostatistics Team. You will plan, analyze, and summarize the results of individual clinical studies or groups of studies (integrated summaries) and assist in coordination of the development and review of regulatory submissions (e.g., NDAs). You will review statistical tables, listings, figures, and analysis datasets for clinical trials in accordance with Catalyst Clinical Research and/or sponsor Standard Operating Procedures (SOPs) or study specific guidelines.  

Position Accountabilities/Responsibilities:

• Support Lead Biostatistician in low to high complexity studies in various phases of development. May lead low complexity studies in exceptional circumstances. 
• Efficiently and effectively coordinate statistical activities for multiple projects simultaneously. 
• Collaborates with internal and external project team personnel (e.g., Sponsor company, external vendors, and within Catalyst Clinical Research) as needed to meet project deliverables and timelines for statistical data analysis and reporting. 
• Interact with project team and line manager to identify project priorities and communicate such activities and associated timelines to departmental management. 
• Serve as primary statistical representative for biometrics standalone projects. 
• Provides statistical advice/recommendations regarding clinical study design/study endpoints, sample size requirements, statistical methodology for the study protocol and clinical study report, and document review/approval. 
• Development of statistical analysis plans based on study specific documents and sound statistical methodology. 
• Assist in developing and maintaining ADaM specifications used in creating analysis datasets, tables, listings, and figures. 
• Ensure the quality and integrity of data analysis and reporting by programming checks using SAS. 
• Monitor project budgets as it relates to the scope of work and support project forecasting efforts.

Supervisory Requirements/Responsibilities:  N/A

Position Qualifications and Requirements: 

Education: 

• Master’s degree, equivalent, or higher in biostatistics or a related field.  
• A satisfactory combination of education and experience may be accepted as a substitute for the specific education and experience. 

Experience:  

• A minimum of 0.5-2 years of relevant work experience.  
• Previous experience in a pharmaceutical research or CRO setting preferred.  
• Prior experience working in Oncology is preferred. 

Required Certifications:  N/A

Required Skills:

• Knowledge or ability to quickly learn clinical trial study design and new therapeutic areas.  
• Able to work independently or with another Biostatistician on multiple, concurrent projects.  
• Capable of conducting exploratory statistical analyses using statistical software packages. 
• Proficient with Microsoft Office Suite. 
• Excellent written and oral communication skills. 
• Excellent presentation skills. 
• Strong organizational, problem-solving, and analytical skills. 
• Ability to manage priorities and workflow. 
• Versatility, flexibility, and a willingness to work within constantly changing priorities. 
• Proven ability to handle multiple projects and meet deadlines. 
• Strong interpersonal skills. 
• Ability to deal effectively with a diversity of individuals at all organizational levels. 
• Commitment to excellence and high standards. 
• Creative, flexible, and innovative team player. 
• Ability to work independently and as a member of various teams and committees. 
• Good judgement with the ability to make timely and sound decisions. 
• Ability to travel for meetings or training activities.  
• Ability to program simple checks for ADaM or TLF review using SAS and/or R. 

Working Conditions: ​​ ​​Sedentary work that primarily involves sitting/standing​.

*Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa.*
 

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