Senior SDTM Statistical Programmer
Ashley Clarke @ RBW consulting is currently recruiting for an Senior Programmer to work remotely on a permanent basis in either UK or Europe.
My client provides a wealth of research knowledge for both biostatistics and operations in the life sciences industries for both software and services. They believe in investing their employees careers with significant professional growth and training. Their motivated staff is the biggest reason to their success.
As the Senior SDTM Programmer your advanced SAS programming skills and proficiency in CDISC standards (SDTM & ADaM) to support or lead one or more Phase I-IV clinical trials, with a focus on any of the following studies; Immunology, Oncology, Cardiovascular, Infectious Disease, Early Development, or Medical Affairs.
- In-depth knowledge of data structures and relevant programming languages for data manipulation and reporting. Knowledge of SAS is required, may include SAS, R, Python, etc..
- Expert knowledge of Define.xml, SDTM aCRF, cSDRGs.
- Expert knowledge of data structures (e.g., CDISC SDTM, CDISC CT) and their implementation.
- Experience in working with SDTM Conformance Checks
- SDTM mapping
- Technical Data Management experience and experience working on a clinical trial.
- Performing data manipulation, analysis and reporting of clinical trial data, both safety and efficacy, utilizing SAS programming;
- Applying your CDISC know-how and proficiency in SDTM and ADaM, to create and validate datasets/analysis files, tables, listings, and figures ( TLF s);
- Generating complex ad-hoc reports
- Preparing and validating submission packages, i.e. define.xml, Reviewers Guide
- Applying your strong understanding/experience with Efficacy analysis;
- Preparing submission packages
- Performing lead duties when called upon;
- Serving as team player, with a willingness to go the extra distance to get results, meet deadlines, etc.
- Being adaptable and flexible when priorities change
Qualification & Experience
- BSc/ MSC degree or equivalent, preferably in a scientific discipline such as Statistics, Computer Science, Mathematics, etc.
- Must have relevant industry experience
- Familiarity with drug development life cycle and experience with the manipulation, analysis and reporting of clinical trials’ data.
- Strong SAS data manipulation, analysis and reporting skills.
- Ability to implement the latest CDISC SDTM / ADaM standards (production/validation). ADaM efficacy dataset development is required.
- Familiarity with pooled data such as in an ISS or ISE or other pooled studies dataset. Experience is preferred but not required.
- Proficiency in SAS MACRO development
- Strong ad-hoc reporting
- Solid experience in Efficacy analysis
- Experience and or familiar with Pinnacle21
- Submissions experience utilizing define.xml and other submission documents such as SDRG, ADRG
- Experience supporting Medical Affairs, Immunology, Cardiovascular, Oncology, Infectious Disease strongly desirable.
- Excellent analytical & troubleshooting skills.
- Ability to provide quality output and deliverables, in adherence with challenging timelines.
- Ability to work effectively and successfully in a globally dispersed team environment with cross-cultural partners.
To find out more about this fantastic opportunity or to discuss other open positions which may be of interest please contact Ashley Clarke on +44 (0) 1273 952 363 and send your CV through using the apply button on this page.
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