- Participate in study preparation (eCRF, and DMP (iDRP and Domain datasets and individual listings) review),
- Participate in study SAS datasets structure (environmental tables) review,
- Develop the Tables, Figures and Listings (TFL) or Table Of Content (TOC) for clinical/Epi studies or assays
- Write t echnical specifications for elimination codes and protocol deviations
- Develop, maintain and document elimination codes and protocol deviations programs
- Write specifications for SAS/R/JMP programs/macros for analyses Datasets (project, study and/or standard),
- Develop, maintain and document SAS/R/JMP programs/macros for study specific analyses (Datasets and analysis)
- Validate (peer review) and document SAS/R/JMP programs/macros for study specific analyses (Datasets and analysis) and elimination codes and protocol deviations programs
- Periodic run and consolidation of elimination codes and protocol deviations
- Pre-Database Freeze cleaning checks on RAW data
- Creation of annexes of Stat report (SR tables, CTRS tables, XML files, ...)
- Provide input on additional analysis request
- Perform Database Documentation for study specific analyses or at the standard level
- Review and ensure adherence to standards at the study or standard level,
- Support quality control (L1 QCs) and quality audit of deliverables,
- Develop, maintain and validate SAS programs for across-projects activities (PLDS, DSUR/PBRER, Web-Disclosure, eSubmission, iDAC)
- Develop, maintain and validate SAS standard macros for core standard activities
- Provide input into workload, technical and process initiatives
- Uses stat methodology to establish study strategy (eg. Power modeling of different scenario, set-up power monitoring, set-up mitigation plan to minimize risk of stat failure)
- Provides input to the concept protocol and protocol (design, objective, endpoint, randomization strategy, sample size, stat analysis)
- Minimum 2 years of experience as statistical analyst/statistical programmer in product development within the pharmaceutical industry.
- Hands-on experience with SAS & R.
- CDISC knowledge: ADAM & TFL.
- Master in Statistics or related areas.
- Experience in multidisciplinary projects.
- Fluent English is required, French is a plus.
- Good communication and teaching skills.
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Statistical Analyst - Waterloo, België - Keyrus Life Science
4 dagen geleden
Beschrijving
What we offer
Joining our consulting team in Belgium means giving your career a step forward. Thanks to the privileged partnership we have with our well-established clients, leaders in their domain, we offer our consultants unique projects to develop their skills, and put their professional experience in the pharma industry on the fast track.
As an expert on the client side, you can count on us to support you at each step of your project thanks to regular touch points with our Key Account Manager. We then also carefully choose with you what would be your next assignment that is matching your career goal whether it is in Consulting or in one of our Functional Services Platforms.
We invest considerable time and resources in training our staff (technical and non-technical courses) to continuously support you in your personal and professional growth. On top of this, you will receive a complete salary package including attractive extra-legal benefits (company car, petrol card, meal vouchers, group insurance, hospitalization...) based on your background and experience.
Job Description
Keyrus Life Science is looking for a Statistical Analyst & Programmer to join our consulting team for a client project based in Walloon Brabant, Belgium . This person will be responsible of the provision of Services in support of Nonclinical or Clinical Statistical services.
This may include (but is not limited to) any of the following:
Profile
Who we are
Keyrus Life Science is an international Consulting, Contract Research Organisation and Functional Services provider with a reputation for transparency and integrity, highly focused on being able to deliver with excellence. Our 'human' approach to service provision is what differentiates us from our competitors. Combined with our high caliber staff, this approach has allowed us to become a key player in clinical research.
At Keyrus Life Science we're proud of our commitment to delivering services of the highest quality, not only skilfully, efficiently and reliably, but also with sincerity and genuine care for our clients' projects, priorities and reputation. Thus we maintain and advance our vision and our standards, all the while ensuring that we serve your interests better.
From early- to late-stage drug development, our range of services includes: Project Management, Clinical Operations, Pharmacovigilance, Quality Assurance (GxP), Regulatory Affairs Strategy & Support, Data Management, Medical Review & Coding, Biostatistics, Medical Writing & Medical Information, Real World evidence services.
