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Senior Manager Programming (SAS Programmer Team Lead)

Entreprise
Celgene Corporation
Lieu
Neuchâtel
Date de publication
29.11.2016
Référence
240158

Description

Senior Manager Programming (SAS Programmer Team Lead)


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 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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