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Associate Director, Statistical Programming

Description Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health.  We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture. PREREQUISITES BA/BS in a relevant scientific discipline; minimum 8-10 years experience as a programmer in a pharmaceutical/CRO setting with a leadership role.  Strong knowledge of data processing and programming requirements for drug development is required, as well as strong knowledge of regulatory requirements and prior experience in managing the programming function. Responsibilities will  include, but are not limited to: Programming Leadership: Responsible for supervising Programmers by planning/assigning their workload Act as a coach and mentor to Programmers Provide training and continued feedback to new programmers to ensure they understand Celgene standards and processes Heavily contributes to development and execution of group strategy Model behaviors, implement new technologies consistent with strategy Proactively anticipate problems, identify root causes and implement creative solutions Leverage networks to achieve influence with others Influence other functions and represent as technical expert Represent as internal team leader who decides best course of action Responsible for performance evaluations and development of direct reports  Responsible for development of performance metrics Partner with staff to create individual development plans Monitor changes in project and study resource needs over time and recruit accordingly CROs and consultant Oversight: Mentor Programmers on CRO database process Monitor progress of database activities in CROs working on Celgene-sponsored studies Participate in Study Team meetings as needed to provide programming expertise and creative solutions to problems        3.   Other Key Activities Author, review and approve SOPs and Working Practices for the department Streamline interface between departments and troubleshoot issues Assist in developing job descriptions for department including roles utilizing new technologies Direct report responsibility for higher level Programmers Monitor the projects to ensure that SOPs are properly followed, and documentation is available Contribute to the development and maintenance of the statistical computing environment to support global usage Oversee the creation, maintenance, and validation standards for programming tools, outputs, and macros Provide training and continuous feedback to new statistical programmers to ensure their proficiency with Celgene standards and processes Conduct special projects as assigned Seek and continually implement best practices Participate in industry-wide technical discussions. Skills/Knowledge Required: BS/BA degree or equivalent in a relevant scientific discipline with a minimum of 8-10 years experience as a programmer Demonstrated management skills and direct management experience required Good communication skills; ability to work in a team environment with medical personnel, clinical monitors, statisticians, data managers and medical writers Knowledge of FDA/ICH guidelines and industry standard practices regarding data capture, clinical data structure, relational database, data processing, analysis programming, and data exchange with alternate formats Medical or mathematics/computer science background a plus Knowledge of SAS to produce derived analysis datasets and TFLs. Understanding of the requirements for SDTM, ADaM, Data Definition Table, and e-submission Knowledge of statistical terminology, clinical tests, medical terminology and protocol design Experience managing programmers, preferred Proficient in programming languages / software Advanced knowledge of reporting tools Good understanding of clinical data and pharmaceutical development Ability to research new technologies and ensure alignment with regulatory agencies and industry standards Req #: 1804071
Salary Range: NA
Minimum Qualification
8 - 10 years

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