5 days ago on ICTCareer.ch

Senior Manager Programming

Celgene Corporation

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 Please refer to JobSuchmaschine in your application

Senior Manager Programming

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

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