Programming Leader - Wavre, België - GSK

GSK

Geverifieerd bedrijf

Wavre, België

2 weken geleden

Geplaatst door:

Sophie Dubois

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Beschrijving

Site Name:
Belgium-Wavre

Posted Date:
Jan

Job Purpose

To provide and manage the programmer/ analyst expertise, manage all programming staff (internal/vendors) and their workload within a project or portfolio and define programming standards to ensure adherence across the Statistical Analyst Team.

Key Responsibilities

Manages and participates in Statistical programming activities across an asset(s) or indication, or in a standard manner to deliver all data analysis outputs
Develops the tables, figures and listings (TFL)
Contributes to defining the strategic programming direction
Governs the quality of statistical programming activities within a portfolio
Oversees the quality and timely delivery of statistical programming activities
Provides stateoftheart programming knowledge / skills for process improvement initiatives
Defines, develops and embeds standards within the Stat Analyst function, project or portfolio in accordance with the Analysis Data Model (ADaM) and Study Data Tabulation Model (SDTM) (datasets, derivation, output definition and implementation).
Provides expert input in the development, promotion and sharing of best programming practices.

Staff Management/Development/Mentoring

Manages all programming staff across an asset(s), indication or standards. Includes staff located in multiple GSK Vaccines sites or vendors sites,
Ensure adequate trainings and mentoring plans to all programming staff across an asset(s), indication or standards.
Acts as "backup" for programming activities when necessary,
Drives capability development as it pertains to technology, standards and associated processes
Participates in the Statistical Analysts allocation or reallocation within and outside the team to be able to mitigate picks and urgencies of the overall Statistical Analysts teams,
Advocates strict adherence to standards and processes by performing random L1 QCs

R&D Pipeline

Develops and justifies the integrity of the programming resourcing strategy

Project Leadership

Leads complex (clinical, nonclinical and epi programming) projects, across the wider Stat Analyst Team. Can successfully take over and lead major projects midstream or at their onset.
Serves as the point of contact for the programming activities for their asset(s) and/or indication(s) or specific expertise (Standards, ADAM).

Vendor Management

Participates in the recruitment of contingent workers or service lines staff

- in collaboration with the vendor project leader initiates and follows newcomer training and mentoring plans

Oversees outsourced statistical programming activities and ensures their performance meets the agreed timelines, quality and budget requirements established for the project, study or specific statistical activities (independent statistical activities, DSUR, PLDS).

_ Why you?_:

Basic Qualifications

Bachelor in Statistics, Mathematics, Informatics or equivalent
SAS programming in pharmaceutical company, data standards (CDISC), ADaM

Preferred Qualifications

Master Degree Statistics, Mathematics, Informatics or equivalent.
At least 5year experience in statistical programming in the pharmaceutical industry or equivalent.
Experience in line management of staff including new project setting.

Other Job-Related Skills/Background

Builds communication strategies to ensure stakeholders are well informed and kept uptodate with all issues on strategy, plans, performance, etc.

- makes sure stakeholders requirements or expectations are met through the effective use of communication of feedback systems,

Can communicate complex ideas at senior levels,
May communicate as GSK technical expert at industry wide external forums (Phuse ),
Creates a culture that values initiative and freedom of action and where a "can do" attitude prevails.
Creates a team spirit and a "ready for help" attitude within the portfolio, within the overall Statistical Analysts team and within the overall BSP team,
Encourages others to take the action to change the internal or external environment to provide greater opportunities and more freedom of action,
Encourages the "one team" spirit in all circumstances to be able to solve technical, expertise or organizational issues.
Provides advice and support when necessary on technical issues outside of the Statistical Analysts team (eCRF, SDTM mapping,) or software challenges
Identifies and leads or contributes to capability
Excellent knowledge of SAS
Excellent knowledge of CDISC (CDASH, SDTM, SEND and ADaM)
Understanding of regulatory process.
Understanding of disease or business area.
Ability to generate /implement ideas/solutions to cross functional strategy. (e.g., outsourcing strategies).
Broad understanding of the endtoend business processes, (e.g., Interventional Human Subject Research studies from protocol creation to database set up, collection and cleaning to statistical and adhoc