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Statistical Programmer II (Berlin, Germany)

Employer
Parexel
Location
Berlin, Germany
Salary
Competitive
Start date
12 Feb 2019
Closing date
14 Mar 2019

View more

Discipline
Data Management / Statistics, Statistics
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

The Statistical Programmer II provides technical expertise for the conduct of clinical trials, and works with
minimal supervision to support various programming activities related to the analysis and reporting of
clinical study data. In addition, the Statistical Programmer II may fill the Statistical Programming Lead role
(or part of that role) on small, non-complex projects.
Key Accountabilities

Deliver best value and high quality service.

Ensure quality control (QC) on all process and technical activities related to derived dataset, table, listing, and figure programming in accordance with corporate quality standards, WSOPs/Guidelines, ICH-GCP and/or other international regulatory requirements are performed.

Assist in the coordination of project start-up activities, including Unix/PMED project area set-up, creation of global programs (e.g. set-up. sas, formats, sas, etc.), tracking spreadsheets, and required documentation.

Assist in the production and QC of derived dataset specifications, programming specifications, and other process supporting documents.

Use efficient programming techniques to produce derived datasets, tables, figures and data listings of any complexity and QC low-medium complexity derived datasets, tables, figures and data listings.

Check own work in an ongoing way to ensure first-time quality.

Maintain all supporting documentation for studies in accordance with WSOPs/Guidelines to ensure traceability and regulatory compliance.

Proactively participate in quality improvement initiatives.

Ensure compliance with WSOPs/Guidelines, ICH-GCP and any other applicable local and international regulations and participate in internal/external audits and regulatory inspections as required.

Develop wider knowledge of SAS and other relevant programming languages and processes within the GRO, Biostatistics, and Medical arenas.

Provide relevant training and mentorship to staff and project teams as appropriate.

Assist project teams in the resolution of problems encountered in the conduct of their daily work.

Create, implement and execute import and export programs, in either standard format, client specific format or CDISC compliant format depending on nature of request.

Develop mapping specification for data exports in accordance with applicable standards.
Qualifications
Skills

Proficiency in SAS.

Knowledge of the programming and reporting process.

Knowledge of WSOPs/Guidelines/System Life Cycle methodologies, ICH-GCP and any other applicable local and international regulations such as 21 CFR Part 11 and proven practical application.

Demonstrate ability to learn new systems and function in an evolving technical environment

Attention to detail.

Ability to successfully work together with a ("virtual") team (including international teams as required) as well as independently.

Demonstrate strong organizational skills, ability to manage competing priorities, and be flexible to change.

Business/Operational skills that include customer focus, commitment to quality management and problem solving.

Work effectively in a quality-focused environment.

Effective time management in order to meet daily metrics or team objectives.

Show commitment to and perform consistently high quality work.

Education

First degree (undergraduate or equivalent) in a relevant discipline is preferred or equivalent work experience.

Language Skills

Competent in written English.

Good communication skills.

Minimum Work Experience

Relevant Clinical Trial industry experience.

Skills

Proficiency in SAS.

Knowledge of the programming and reporting process.

Knowledge of WSOPs/Guidelines/System Life Cycle methodologies, ICH-GCP and any other applicable local and international regulations such as 21 CFR Part 11 and proven practical application.

Demonstrate ability to learn new systems and function in an evolving technical environment

Attention to detail.

Ability to successfully work together with a ("virtual") team (including international teams as required) as well as independently.

Demonstrate strong organizational skills, ability to manage competing priorities, and be flexible to change.

Business/Operational skills that include customer focus, commitment to quality management and problem solving.

Work effectively in a quality-focused environment.

Effective time management in order to meet daily metrics or team objectives.

Show commitment to and perform consistently high quality work.

Education

First degree (undergraduate or equivalent) in a relevant discipline is preferred or equivalent work experience.

Language Skills

Competent in written English.

Good communication skills.

Minimum Work Experience

Relevant Clinical Trial industry experience.

Company

Parexel International Corporation is a leading global biopharmaceutical services organization, providing a broad range of knowledge-based contract research, consulting, and medical communications services to the worldwide pharmaceutical, biotechnology and medical device industries. Committed to providing solutions that expedite time-to-market and peak-market penetration, Parexel has developed significant expertise across the development and commercialization continuum, from drug development and regulatory consulting to clinical pharmacology, clinical trials management, medical education and reimbursement. Parexel Informatics, Inc., a subsidiary of Parexel, provides advanced technology solutions, including medical imaging, to facilitate the clinical development process.

 

Mission: Parexel’s mission is to combine the strength of our expertise, experience and innovation to advance the worldwide success of the bio/pharmaceutical and medical device industries in preventing and curing disease.

 

Company info
Website
Telephone
+44 1895 238000
Location
The Quays
101-105 Oxford Road
Uxbridge
Middx
UB8 1LZ
GB

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