4 days ago on jobs.celgene.com

Senior Manager Programming

Celgene Switzerland SA

  • Work region
  • Sector
  • Employment type
  • Position

 Please refer to JobSuchmaschine in your application

Senior Manager Programming

Senior Manager Programming

Req #:16001846
Job Category:Clinical Operations
Work Location:Boudry, Switzerland Route de Perreux 1 Boudry 2017
Organization:Celgene R&D Sarl
Shift:Day Job
Employee Status:Regular
Job Type: Standard
Job Level: Manager
Travel:Yes, 10 % of the Time


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 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





• 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