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

Celgene (company)

Posted on : 26 December 2016

Project Description

Responsibilities 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 company 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 company-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  

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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