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Senior Manager Programming (SAS Programmer Team Lead) Boudry Switzerland,  

Posted on : 26 December 2016

Project Description

Req #: 16001846 Location: BOUDRY, NE CH Job Category: Clinical Operations Work Location: Boudry, Switzerland Route de Perreux 1 Boudry 2017 Organization: Celgene R&D Sarl Schedule: Full-time Shift: Day Job Employee Status: Regular Job Type: Standard Job Level: Manager Travel: Yes, 10 % of the Time DescriptionResponsibilities will  include, but are not limited to: 1. 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 " Participate in the development and execution of group strategy " Resolve problems as they arise within defined procedures " Begin building networks to achieve influence with others " Influence other functions and represent as CDOSS technical expert " Represent as internal team leader who decides best course of action " Responsible for performance evaluations and development of direct reports 2. Programming Support: " Provide programming input to CRF, SAP, analysis file specifications, and tables, figures, and listings (TFLs) shells " Write SAS programs to generate derived analysis datasets, perform analysis, and TFLs " Perform ad hoc flexible and rapid programming arising from questions generated from planned analyses and results " Provide programming support for the preparation of integrated reports, submissions and post-submission activities " Serve as the lead programmer in support of NDAs, sNDAs 3. CRO and consultant Oversight: " Coach Programmers on CRO database process " Monitor progress of database activities in CROs working on Celgene-sponsored studies " Participate in Study Team meetings as needed, especially in a supportive capacity        4.   Other Key Activities " Author, review, approve and train on CDOSS SOPs and Working Practices for the department " Contribute to the creation, maintenance and validation of standards for programming tools, outputs and macros; and offering training on the same " Ensure consistency and adherence to standards within their therapeutic area. " Contribute to the creation of naming conventions and standards for the programming environment. " Build interfaces between departments and troubleshoot issues as needed " Assist in developing job descriptions for department including roles utilizing new technologies such as EDC " Direct report responsibility for higher level Clinical Programmers " Monitor projects to ensure that SOPs are properly followed and documentation is available " Conduct special projects as assigned " Sharing of best practices " Participate in industry wide technical discussions   *LI-NS1  Qualifications " BS/BA degree or equivalent in a relevant scientific discipline with a minimum of 8-10 years experience as a Clinical Programmer and SAS Programmer " Supervisory experience a plus " Good communication skills; ability to work in a team environment with medical personnel, clinical monitors, statisticians, data managers and medical writers " In-depth knowledge of FDA/ICH guidelines and industry/technology standard practices " Medical or mathematics/computer science background a plus " Detailed knowledge and experience in CRF design, central laboratories, programming databases, query resolution, data validation " Computer skills: detailed knowledge of at least one data management systems, basic familiarity with SAS datasets and conversion procedures " Experience managing programmers, preferred " Knowledge of clinical study design, Proficient in programming languages / software " Advanced knowledge of reporting tools. " Advanced knowledge of database design and programming practices " Good understanding of clinical data and pharmaceutical development " Demonstrated proficiency in using SAS to produce derived analysis datasets and produce TFLs " Thorough understanding of clinical data structures, relational database structures, and data exchange with alternate data formats " Demonstrated expertise in the handling and processing of upstream data, e.g., multiple data forms, workflow, eDC, SDTM " Demonstrated expertise in providing outputs to meet downstream requirements, e.g., ADaM, Data Definition Table, e-submission " Good knowledge of statistical terminology, clinical tests, medical terminology, and protocol designs



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