Biostatistician, SAS Programmers, Clinical Data Manager (Brussels, Belgium)

The BUSINESS & DECISION Group with more than 2500 Consultants in more than 30 locations throughout Europe and the world is a recognized leader for consulting services in the areas of Business Intelligence, Customer Relationship Management (CRM), Electronic Commerce and Life Sciences. It offers an international professional environment in a fast-growing, cutting edge sector. B&D Life Sciences (Brussels) is a fast growing company (around 55 Consultants) whose customers are mainly reputed life sciences companies in the area of pharmaceuticals, medical devices, biologicals and biotechnology. It is proud to keep alive its values of openness, fairness, respect and conviviality. B&D Life Sciences is committed to creating a friendly, pleasant and stimulating surrounding in which the individual, to the extent of his or her ambitions, can fully evolve through permanent learning and stimulating assignments. Differences and individual preferences are accepted and respected. During its 20 years of activities in the area of clinical and pre-clinical Research & Development, B&D Life sciences has developed its core competencies around biometrics and biostatistics. To expand its activities in biometrics, B&D Life Sciences is continuously recruiting biostatisticians from all levels of experience and expertise. Statistical/SAS programmers (for pharmaceutical/CRO business unit)

Function Description:

• Provide statistical programming support and validation of analysis datasets and statistical analyses
• Program analysis datasets, pooled datasets, listings, tables, summaries and graphs for clinical trials
• Assist in statistical quality assurance review and program validation
• Provide input in design of databases and analysis
• Automation and standardization of statistical analysis routines
• Document programming procedures and coding
• Perform other related duties incidental to the work described above

Profile:

• Bac +2 to +5 in (Bio)Statistics, Computer
• Science, Life Science or related field
• Minimum of 1 year biotech/pharmaceutical/CRO experience
• Experience with SAS programming is required
• Understanding of clinical trial practices, procedures and methodologies

Skills:

• Strong computer and analytical skills
• Good written and verbal communication skills
• Problem solving mentality
• Set priorities and respect tight deadlines
• Team player

Technology :

SAS (BASE, STAT, MACRO, IML, PROC SQL) S+ or R is an asset Microsoft Office

Offer:

Besides an attractive compensation package (including company car and extra-legal benefits), BUSINESS & DECISION offers a flexible career path allowing consultants to enjoy at each level a maximum degree of empowerment and room for initiative. The success of the company is based on the continuous personal development of our consultants through implication in a variety of exciting assignments in a cutting edge professional environment.

Location: All of our customers are located in Belgium, and mostly within a 40 kilometer radius from Brussels.

Biostatistician (for pharmaceutical/CRO business unit)

Function Description:

The candidate is responsible for implementing and executing methodological and statistical aspects of clinical studies.

• Prepare statistical analysis plan and write detailed specifications for analysis files, consistency checks, tables and figures
• Communicate with client regarding statistical analysis issues
• Interpret analyses and write statistical sections of study reports
• Develop study plans for individual clinical trials, including experimental design, randomization, sample size, parameters for analysis and methods of analysis
• Conduct statistical analyses and perform QC
• Collaborate in writing study protocols and amendments, including the responsibility for writing the data evaluation section, sample size calculation and analysis plans
• Review CRF's and ensure their design meets protocol criteria, and contain all data required to support a high quality database and planned analysis
• Participate in programming development
• Datamining on large databases
• Prepare statistical reports for regulatory submission and defend statistical conclusions with various regulatory agencies.
• Contribute to writing manuscripts
• Perform other related duties incidental to the work described above

Profile:

• PhD or masters' degree in (bio)statistics
• 2-5 years experience in clinical research and has
• a previous experience as biostatistician in a pharmaceutical or CRO environment
• Has experience with SAS programming
• Excellent knowledge of ICH/GCP
• Works independently with low supervision

Skills:

• excellent analytical skills
• excellent English writing skills
• problem solving mentality
• detail oriented
• set priorities and respect tight deadlines
• effective communication skills
• team player

Technology :

SAS S+/R is an asset PASS and/or Nquery (samply size calculation)

Offer:

Besides an attractive compensation package (including company car and extra-legal benefits), BUSINESS & DECISION offers a flexible career path allowing consultants to enjoy at each level a maximum degree of empowerment and room for initiative. The success of the company is based on the continuous personal development of our consultants through implication in a variety of exciting assignments in a cutting edge professional environment.

Location: All of our customers are located in Belgium, and mostly within a 40 kilometer radius from Brussels.

Clinical Data Manager (for pharmaceutical/CRO business unit)

Function description:

The Clinical Data Manager is a key member of a multidisciplinary team involved in setting up, running and reporting of clinical trials. He/she processes clinical trial data, using a range of software applications and database systems to support collection, cleaning and management of patient data, while respecting high quality standards.

• Contribute to the design of protocols, specifically related to data management and study design.
• Contribute to design of CRF's and CRF completion guidelines
• Design and validate database according to the applicable quality standards and guidelines
• Identify inconsistencies in CRF data and ensure resolutions
• Ensure completeness, accuracy and consistency of collected data
• Provide database/eCRF/data review trainings
• Track and report on progress of data collection/cleaning
• Perform data coding, SAE and external database reconciliation prior to database locking
• Assume responsibility for timely delivery of a clean, quality controlled database
• Contribute to standardising data management procedures
• Perform other related duties incidental to the work described above

Profile:

• Masters degree in scientific or healthcare discipline or equivalent through experience
• A minimum of 2-4 years experience in a clinical trial environment
• Previous experience as Clinical data programmer/Clinical data reviewer in a pharmaceutical or CRO environment is required, as well as experience in database development
• Excellent knowledge of ICH/GCP
• Works independently with low supervision

Skills:

• computer skills
• strong planning & organizational skills
• team player
• problem solving mentality
• detail minded
• committed to work according to strict quality standards

Technology :

Ms Office Oracle Clinical and/or Clintrial SAS is a plus

Offer:

Besides an attractive compensation package (including company car and extra-legal benefits), BUSINESS & DECISION offers a flexible career path allowing consultants to enjoy at each level a maximum degree of empowerment and room for initiative. The success of the company is based on the continuous personal development of our consultants through implication in a variety of exciting assignments in a cutting edge professional environment.

Location: All of our customers are located in Belgium, and mostly within a 40 kilometer radius from Brussels.

Application:

If you fit this profile, please send your cv to: Jerry Welkenhuysen-Gybels (jerry.welkenhuysen [at] businessdecision.com) or B&D, rue de la revolution 8 omwentelingsstraat, 1000 Brussels.

URL: www.datashaping.com/jobs16741e.shtml Please mention datashaping.com when applying. Thank you.