Specialist, Clinical Data Management

Who We Are:

Neurocrine Biosciences is a leading biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are 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 for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, hyperphagia in patients with Prader-Willi syndrome, endometriosis* and uterine fibroids*, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For more than three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders, because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, X, Facebook and YouTube. (*in collaboration with AbbVie)

About the Role:Collaborates with various departments on the design, documentation, testing and implementation of clinical data studies. Develops systems for organizing data to analyze, identify and report trends. Analyzes the interrelationships of data and defines logical aspects of data sets. Prepares reports of clinical trial studies for internal validation and cross validation studies. May evaluate and resolve issues regarding contents of reports.

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Your Contributions (include, but are not limited to):

• 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

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

Neurocrine Biosciences is an EEO/Disability/Vets employer.

We are committed to building a workplace of belonging, respect, and empowerment, and we recognize there are a variety of ways to meet our requirements. We are looking for the best candidate for the job and encourage you to apply even if your experience or qualifications don’t line up to exactly what we have outlined in the job description.

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The annual base salary we reasonably expect to pay is $89,800.00-$123,000.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In addition, this position offers an annual bonus with a target of 20% of the earned base salary and eligibility to participate in our equity based long term incentive program. Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.