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[Permanent] Clinical Data Manager – Data Integration Specialist at Business & Decision

2011-08-25 04:37:02

Location: Belgium
URL: http://www.businessdecision-lifesciences.com/

Description:

Business & Decision is a multi-national consulting company specializing in services and solutions for the Life Sciences Industry, most importantly in data management, SAS programming, biostatistics, medical writing and clinical trials expertise.

With more than 100 clients in Belgium and Europe, including most major players in the pharmaceutical/clinical sector, and a CDISC recognized partner, we are one of the best in our field.

Function description:
The Clinical Data Manager – Data Integration Specialist is a key member of a multidisciplinary team involved in implementing CDISC data standards in clinical trials.
As such, you convert legacy (or on-ongoing) clinical study data and metadata into a CDISC format in order to comply with the Food and Drug administration (FDA) submission requirements, or prepare clinical data into a data warehouse ready format in order to maximize its usability.

In this process, your main responsibilities are as follows:

Content and structure analysis of the legacy data and the clinical trial protocol
Annotation of Case Report Forms using CDISC Terminology
Preparation of clinical data CDISC conversion definitions
Development of project documentations (Data Reviewers Guide and Data Handling Report)
Validation of the data and metadata according to the applicable CDISC standards and guidelines
Quality Control of all project deliverables
Responsibility for the timely delivery of a CDISC-compliant submission package
Contribution to the definition of CDISC validation checks

Profile:

Master’s degree in scientific or healthcare discipline or equivalent through experience
A minimum of 1 to 3 year(s) experience in a clinical trial environment
Strong understanding of data management and database administration: clinical protocol assessment, Case Report Form design, understanding of clinical data management systems, study start up (database administration, edit check creation/validation) and data base lock.
CDISC knowledge is a plus
Good knowledge of ICH/GCP
Basic SAS knowledge
Good English written and oral communication skills
Quick learner
Excellent team player
Able to plan work in order to meet deadlines

Offer:

We offer you the opportunity to be trained on the CDISC data standard with us as European leader in this domain.

At Business & Decision Life Sciences, you will be working in a pleasant environment 5 minutes away from the metro and the Ring, with flexible hours as well as an extensive package including company car and fuel card, net allowances, expenses, full group and hospitalization insurance coverage, etc.

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[Permanent] Senior Biostatistician - Germany at Stelfox

2011-08-03 11:27:44

Location: Germany
URL: http://www.stelfoxuk.com

Description:

Great opportunity has arisen for an experienced Senior Biostatistician to join a very fast growing pharmaceutical company based in Germany.

Responsibilities:

• Providing statistical input at the clinical project and trial level in alignment with the overall clinical strategy
• Applying “state-of-the-art” statistical modeling, simulation, predictions and analysis methods for optimizing trial designs and clinical development programs
• Writing statistical plan, conducting data analyzes, interpreting, presenting and reporting statistical results
• Looking for opportunities for applying innovative statistics to research and development of new drugs
• Providing input to the clinical part of regulatory documents and representing statistics at regulatory authorities and in the scientific community
• Working according to ICH-GCP and ICH-biostatistics guidelines

Qualifications:
• experience in biostatistics in the pharmaceutical industry within a fast paced, change driven and international environment
• You have a University degree in mathematics/statistics, biometry or equivalent degree
• You have experience at interacting with very senior levels and effective at interacting with all levels of employees across highly matrixes organization

This role is offering a very competitive salary package for the right candidate.

If you have the skills and experience for this opportunity please email your C.V. to Andrea@stelfoxuk.com or call +441273 727 930 for further details.

Andrea is a Clinical Operations Search/ Biometrics expert at Stelfox Pharmaceutical Search covering Europe, UK, North America and Asia.

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[Permanent] Senior SAS programmer - Germany at Stelfox

2011-08-03 11:10:28

Location: Germany
URL: http://www.stelfoxuk.com

Description:

Exciting opportunity to join a very fast growing pharmaceutical company based in Germany.

Responsibilities:
• State-of-the-art SAS programming (programming of statistical analyses, tables, figures and listings)
• Developing, applying and maintaining standard SAS programs and macros
• Data pooling and data mapping
• Reviewing of annotated CRFs
• Validating SAS programs
• Defining, implementing and maintaining data standards (SDTM, ADaM) and SAS dataset structures
• Implementing and maintaining a Clinical Data Repository / Data Warehouse
• Working according to ICH-GCP and ICH-biostatistics guidelines

Qualifications:

• experience in biostatistical programming in the pharmaceutical industry within a fast-paced, change driven and international environment
• You have excellent skills in SAS programming (SAS/Base, SAS/Stat, SAS/Graph, SAS/AF, SAS/Macro, SAS/SQL, SAS Data Integration Technologies

This role offers a great salary + bonus package for the right candidate.

If you have the skills and experience for this opportunity please email your C.V. to Andrea@stelfoxuk.com or call +441273 727 930 for further details.

Andrea is a Clinical Operations Search/ Biometrics expert at Stelfox Pharmaceutical Search covering Europe, UK, North America and Asia

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[Permanent] Senior SAS programmer - Germany at Stelfox

2011-08-03 11:00:48

Location: Germany
URL: http://www.stelfoxuk.com

Description:

Excellent opportunity for an experienced Senior SAS programmer to join one of the leading pharmaceutical companies based in Germany.

Main Responsibilities:

– Self-employed, GCP-compliant implementation of the entire statistical analysis of clinical trial data based on specifications of the study and project statistician – Efficient, scientific programming of analysis datasets, tables, graphs and lists with the SAS software for clinical study reports, registration documents and publications – Acting as a responsible programmer for international development projects – Advancing the international development of quality standards of the SAS programming and the creation of generic program modules and libraries for repetitive tasks of reporting – Development, optimization and establishment of the instruments required for this

Qualifications:

- degree in computer science, mathematics or medical documentation or a comparable education and a sound knowledge of descriptive statistics

– very good programming skills in SAS, particularly in the SAS macro language, and good knowledge of SAS GRAPH

If you have the skills and experience for this opportunity please email your C.V. to Andrea@stelfoxuk.com or call +44(0)1273 727 930 for further details.

Andrea is a Biometrics expert at Stelfox Pharmaceutical Search covering Europe, UK, North America and Asia.

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[Permanent] SAS programmer at Stelfox

2011-08-03 10:52:38

Location: Germany
URL: http://www.stelfoxuk.com

Description:

Fast growing CRO company based in the Frankfurt area in Germany is looking for an experienced SAS programmer to join their company ASAP.

Responsibilities :

• To support the generation and review of the procedures, guidelines, manuals and/or other documents applicable to the general or project-related biostatistical activities. Specifically, to generate, evaluate and validate SAS programmes as required within the evaluation process. This also includes to perform plausibility checks and other quality control actions in biostatistical areas, and to generate tables, lists, diagrams and other data presentation tools as requested by sponsor and/or company directives.
• To report to the line manager on the biostatistical activities. This activity includes to generate, review, update, submit and archive these reports as required.
• If requested, to support the creation of a biostatistical team, as well as the set-up and evaluation of the methodology applicable to each project. Additionally, to support the control of timelines of each project, and to implement actions in case of problems.

Qualifications:

– Degree in statistics (or equivalent degree) – relevant experience required, including experience in Pharma – knowledge of statistical software packages; strong knowledge of SAS – knowledge of S+

If you have the skills and experience for this opportunity please email your C.V. to Andrea@stelfoxuk.com or call +441273 727 930 for further details.

Andrea is a Clinical Operations Search/ Biometrics expert at Stelfox Pharmaceutical Search covering Europe, UK, North America and Asia.

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[Permanent] Senior/SAS programmer - GERMANY at Andrea Lakos

2011-08-03 10:41:48

Location: Germany
URL: http://www.stelfoxuk.com

Description:

Great opportunity has arisen for an experienced SAS programmer to join one of the leading biopharma companies in Germany.

Responsibilities:

• State-of-the-art SAS programming (programming of statistical analyses, tables, figures and listings)
• Developing, applying and maintaining standard SAS programs and macros
• Data pooling and data mapping
• Reviewing of annotated CRFs
• Validating SAS programs
• Defining, implementing and maintaining data standards (SDTM, ADaM) and SAS dataset structures
• Creating and running import and export routines for internal/external data
• Cooperating with Clinical Research Organizations
• Working according to ICH-GCP and ICH-biostatistics guidelines

Qualifications:

• You have proficiency and profound experience in biostatistical programming in the pharmaceutical industry within a fast-paced, change driven and international environment
• You have excellent skills in SAS programming (SAS/Base, SAS/Stat, SAS/Graph, SAS/AF, SAS/Macro, SAS/SQL, SAS Data Integration Technologies)
• You have a university degree in mathematics/statistics/informatics or equivalent education in data processing/programming

This role is offering a great salary package, trainig and other benefits for the right candidate.

If you have the skills and experience for this opportunity please email your C.V. to Andrea@stelfoxuk.com or call +44(0)1273 727 930 for further details.

Andrea is a Biometrics expert at Stelfox Pharmaceutical Search covering Europe, UK, North America and Asia.

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[Permanent] Technical Regulatory Manager - Switzerland - Permanent at SEC Pharma

2011-06-29 09:00:56

Location: Switzerland
URL: http://www.secrecruitment.com

Description:

Technical Regulatory Manager – Switzerland – Permanent

My client is a large global pharmaceutical company, which is currently looking for an experienced Technical Regulatory Manager to join their team of top professionals based in their office in Switzerland. You need to be experienced with all regulatory activities to do with the quality regulatory documentation (CMC, Module 3) required for Clinical trial and Marketing approval for FDA and EMA.

Responsibilities:

• Strategic leadership and regulatory decision making for multiple small molecule and peptide development products
• Represent the technical regulatory function of the company
• Shape the technical regulatory strategy within international project teams
• Coordinate the preparation and filing of the quality regulatory documentation
• Participate in international health authority meetings

Requirements: • At least a Bachelor’s Degree, but preferably a PhD degree in pharmaceutical sciences, chemistry or related technical fields • Minimum 5 years of experience in technical regulatory, pharmaceutical development, production or quality. • Good knowledge of Global regulatory requirements • Excellent written and oral communication, presentation and negotiation skills • Fluent spoken and written English and a good knowledge of German are a must.

This is a fantastic chance to work for a company where you have the opportunity to pursue your interests across functions and geographies, and where a job title is not considered the final definition of who you are, but the starting point.

Please, send your CVs to Nikolay.Dimitrov@secpharma.com
Or
Call +44 (0)20 7255 6600 and talk to Nikolay Dimitrov

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[Permanent] Senior Statistical Programmer - 110620A at SEC Pharma

2011-06-20 19:43:02

Location: United Kingdom
URL: http://www.secrecruitment.com

Description:

HOMEBASED | Senior Statistical Programmer | Perm | UK | HOMEBASED

HQ in SE England – Competitive Salary + Benefits

My client is seeking a programmer to take responsibility for both production and QC of derived data sets, data listings, data summaries, figures and statistical appendices for global trials across all phases. This role would include being lead programmer on projects with responsibility for planning and coordination of activities for assigned team members.

Summary of job description

- Program and QC analysis datasets, pooled datasets, listings, summaries, figures and tables for phase I-IV clinical trials and for overall summaries of safety and efficacy. – Production and QC of study specifications for analysis datasets and pooled datasets. – Provide input as appropriate into specifications for data listings, data summaries/tables and figures for phase I-IV clinical trials, and for overall summaries of safety and efficacy, to ensure adherence appropriate standards – Produce good quality SAS programs – Document all work in clear and logical fashion ensuring that program and project documentation are maintained. – Provide programming input into CRFs and data management plans as well as programming aspects of SAPs – Input into estimation of task durations for programming deliverables. – Liaise with internal and external parties on programming aspects of projects. – Perform role of Lead Programmer on selected studies acting as consultant where necessary. – Supervise and train junior team members, inputting into appraisal reports.

Experience Required – Minimum of BSc/BA or equivalent in computer science, mathematics, statistics, life sciences or similar. – Excellent and proven SAS programming skills (BASE, MACRO, GRAPH). – Knowledge and experience in database design and structures. – At least 4 years experience in programming in a clinical trials environment or in a related field. – Good knowledge of statistical principals underlying clinical trials. – UK experience is essential.

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[Permanent] Regulatory Submissions Manager - London (ENG), Munich (GER), Stirling SCO at Nikolay Dimitrov

2011-06-20 16:09:09

Location:
URL: http://www.secrecruitment.com

Description:

Regulatory Submissions Manager – Permanent
Germany; England; Scotland

My client is a global CRO specializing in a number of therapeutic areas. As an addition to their headquarters in USA and operations worldwide, they are currently witnessing a rapid growth in their European activities.

On this occasion they are looking for Regulatory Submissions Managers to join their experienced and specialized clinical trial management teams in their offices in Germany, England and Scotland.

As a Regulatory Submissions Manager you will be responsible for managing and executing all aspects of global start-up. You will have background experience in clinical trials ideally within a Regulatory or Start-up role.

Key responsibilities:

• Perform quality checks on submission documents
• Provide advice regarding regulatory requirements for items such as labelling and submission documentation;
• Interact with international ethics committees and regulatory agencies;
• Be aware of changing regulations to develop proactive solutions to regulatory issues and challenges

Requirements:

• Minimum a Bachelor’s Degree in any related subject
• Knowledge of ICH guidelines and applicable local regulations regarding the conduct of clinical trials;
• Excellent written and oral skills;
• Advanced computer knowledge, especially with Microsoft® Office, is desired.

This is a fantastic opportunity to join a continuously growing company with an international team and further progress your career in a stimulating and challenging work environment.

Please send your CV to Nikolay.dimitrov@secpharma.com or call 0044 (0)20 7255 6600

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[Permanent] Regulatory Submissions Manager at Nikolay Dimitrov

2011-06-20 16:06:56

Location: United Kingdom
URL: http://www.secrecruitment.com

Description:

Regulatory Submissions Manager – Permanent

On this occasion they are looking for Regulatory Submissions Managers to join their experienced and specialized clinical trial management teams in their offices in Germany, England and Scotland.

Key responsibilities:

Requirements:

This is a fantastic opportunity to join a continuously growing company with an international team and further progress your career in a stimulating and challenging work environment.

Please send your CV to Nikolay.dimitrov@secpharma.com or call 0044 (0)20 7255 6600

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