Specialist, Clinical Data Management

Neurocrine Biosciences • San Diego, CA

5d

About The Position

Neurocrine Biosciences is a leading biopharmaceutical company dedicated to discovering, developing, and commercializing life-changing treatments for patients with under-addressed neurological, psychiatric, endocrine, and immunological disorders. The company's diverse portfolio includes FDA-approved treatments and a robust pipeline. The Specialist, Clinical Data Management collaborates with various departments on the design, documentation, testing, and implementation of clinical data studies. This role develops systems for organizing data to analyze, identify, and report trends, analyzes the interrelationships of data, and defines logical aspects of data sets. The specialist prepares reports of clinical trial studies for internal validation and cross-validation studies and may evaluate and resolve issues regarding the contents of reports.

Requirements

• BS/BA degree and 2+ years of relevant experience, OR Master’s degree and some related experience, OR JD or PharmD or PhD and some related experience
• Understands Neurocrine's business objectives and developing understanding of Neurocrine's services and customers
• Has experience in specific functional discipline while working to acquire higher-level knowledge and skills
• Comfortable with tools and processes that support work conducted by functional area
• Ability to work as part of a team
• Strong computer skills
• Good communications, problem-solving, analytical thinking skill
• Detail oriented
• Ability to meet deadlines
• Good project management skills
• Thorough understanding of data management processes is essential
• Strong SAS skills required
• Excellent oral and written communication skills are required

Responsibilities

• Collaborate with Clinical Research scientists, consultants, and other biostatisticians in the development of clinical trial protocols
• Select optimal experimental designs, defining endpoints, and identifying and/or developing appropriate statistical methods of analysis for protocols developed in-house as well as by Contract Research Organizations (CROs)
• Participate in the development and review of clinical trial data capture processes and media, including electronic data capture methods and paper case reports forms (CRFs)
• Ensure that all protocol-required data are collected in consistent formats that reflect any applicable standards
• Review and approve data management plans and database quality control/audit plans prepared by CROs
• Ensure that appropriate data edit check specifications, quality control checks, and audit procedures are implemented
• Prepare and approve statistical analysis plans, and collaborate with CRO biostatisticians in the preparation of statistical analysis plans as necessary
• Ensure that statistical analysis plans completely describe all appropriate statistical methods and provide detailed specifications for summary tables, figures, and listings
• Oversee and monitor CRO performance of biostatistics and data management tasks to ensure that timelines are met and that any resource issues are identified and resolved
• Provide biostatistical support to non-clinical areas of the company, including consulting and data analysis
• Assist in the development of department standard operating procedures, statistical analysis plans, report templates, and standardization of CRFs
• Select and implement statistical software

Benefits

• Retirement savings plan (with company match)
• Paid vacation, holiday and personal days
• Paid caregiver/parental and medical leave
• Health benefits to include medical, prescription drug, dental and vision coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level