12 Months Contract
70 - 90 EURO P/H
Provide advanced level of SAS programming activities for the monitoring
Collaborate with project biostatistician in the creation, implementation, and maintenance of execution plan accounting for timeline, resource and quality of the projects
- Ensures that all statistical programs comply with the programming coding standards and utilize available standard reporting systems, as well as macro utility programs.
- Support statistical programming applications that are used to generate clinical study reports.
- Support ADS and TLG generation, and assist with the development of work flow and SOPs for Biostatistics and Statistical Programming operations.
- Accountable for the provision of standard and non-standard data sets, tables, listings and figures based on the final synopsis and SAP that are required for the study reports, submissions and product defense.
- Communicates effectively not only within the teams and functional lines but also with the external resources
- Provides filing, approval and regulatory programming support for all aspects of a submission
Degree in life sciences, statistics, biostatistics, or equivalent areas with extensive experience in pharmaceutical industry, medicine or a relevant field is preferred.
Extensive SAS programming skills
Knowledge of base SAS, SAS macro language, graph, FSP, STATS, SQL as well as other programming languages.
- Knowledge of Unix system, Oracle Clinical and EDC (electronic data capture) exposure preferred excellent analytical, problem solving, and computer skills.
- Basic knowledge of FDA/ICH guidelines, the software development life cycle, and 21 CFR Part 11 and other FDA regulations.
To find out more details, please feel free to get in touch with Russell Gillam on +44 255 6665 OR send your CV to [log in to unmask]<mailto:[log in to unmask]>
Statistician - 12 Months Contract - South Netherlands
60 - 70 EURO P/H
Varied and Interesting Position
Your Key Duties and Responsibilities:
Writes analysis plans and statistical reports and reviews joint clinical/statistical reports.
* Oversees development of statistical tables and data listings.
* Reports statistical results summarizing the results of multiple trials for publications or regulatory submissions.
* Plans methods to collect information and reviews or develops case report forms according to study design. Assists in the design of clinical databases.
* Evaluates reliability of source information, adjusts and weighs raw data, and organizes results into form compatible with analysis by computers or other methods.
* Instructs clinical research staff on applicable statistical principles.
* Bachelor's degree (BA/BS) and five to seven years related experience
* 4 Years' Experience
* Language Skills: Ability to read, analyze, and interpret scientific and technical journals, statistical texts, government regulations, financial statements, and legal documents.
* Ability to respond to inquiries or complaints from customers, regulatory agencies, or members of the business community.
* Ability to write articles for publication that conform to prescribed style and format.
* Ability to develop presentations, operating procedures, procedure manuals, and business correspondence.
* Ability to effectively present information to top management, public groups, and/or boards of directors. Ability to explain statistical concepts and results of data analyses to non-statistical audiences and project team members.
* Mathematical Skills: Ability to comprehend and apply principles of advanced calculus, modern algebra, probability and advanced statistical theory.
* Ability to work with concepts such as probability distributions, limits, rings, quadratic and differential equations, and proofs of theorems.
* Computer Skills: Mastery of at least one statistical programming language (e.g., SAS). Competency with Microsoft Word and Excel.
* Familiarity with the concepts of database structure. Ability to work with data processing, programming, systems design, problem, analysis, and hardware.
For a confidential discussion, please feel free to get in touch on:
Researcher - Statistics, Biostatistics & Programming
Pharmaceutical, Healthcare & CRO Division
Tel: +44 (0) 207 255 6665
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