Overall Purpose of the Position: While project vary, your typical responsibilities might include collaborating and communicating with a variety of colleagues and customers. You will also need to be detail focused, with a real understanding of the importance of quality in everything related to your role at TASK. The main responsibilities of this position are to produce analysis datasets, tables, listings, and figures for study statistical analysis and regulatory submissions. To provide technical support in the review and development of programming specifications, statistical analysis plans, and reports. To support the Data Management team with the development and production of analysis dataset QC programs. Other responsibilities, which are secondary include the programming of Data Reconciliations and Manual Review Listings, SDTM Sponsor/Statistician Listings, and Database Edit Specifications. Join our growing team and discover your extraordinary potential by working as a Clinical Programmer II. You will work in our Data Management team so you will enjoy a varied role working for different sponsors across several therapeutic areas within phases I-IV. The position offers a strong support network, flexible working solutions, and the opportunity to progress your career. If you are looking to strengthen your Lead expertise within a varied and dynamic environment, then this is a fantastic opportunity. Key Performance Areas (KPAs)&Responsibilities include, but not limited to: • Programming of PK, Safety and Efficacy Analysis Datasets based on SAPs, (Data Definition Tables) DDTs, CDISC ADaM and ICH E9 Guidelines • Programming of TFLs based on SAPs, CSR and ICH E3 Guidelines • Programming of Analysis Datasets and TFL QC programs • Producing Define XML / PDFs, Analysis Results Metadata (ARM), and Reviewers Guides to support SDTMs and ADaMs. • Reviewing of DDTs and SAP programming specifications • Reviewing of Statistical Reports and Methodologies • Quality checking of Analysis Datasets and TFLs Secondary Performance Areas&Responsibilities include, but not limited to: • Programming of Data Reconciliations and Manual Review Listings • Programming of SDTM Sponsor/Statistician Listings • Programming of Database Edit Specifications • Statistical Reviewing of aCRFs Ideal Requirements • Minimum of Diploma or Bachelors or Master’s in computer science, Mathematics, Engineering or equivalent • Experience in R Programming OR SAS Base, SAS graph and SAS Macros • Excellent knowledge of CDISC standards (SDTM and ADaM) • Excellent knowledge in ICH E9 Guidelines • Knowledge and Experience with Clinical Trial Data • Understanding of Clinical Relation Database application and theory • Knowledge of ICH-GCP with a strong interest in clinical research • Professional use of the English language; both written and verbal • High ethics and good programming practice skills • Advanced computer skills Key Personal Inherent Characteristics • Delivering high performance and an excellent communicator who listens effectively and accurately and clearly conveys information through verbal and written means • Driving quality by displaying ability to clarify and reduce complex issues to simple solutions • Ability to anticipate problems and resolve problems before they occur • Recognize recurring issues and analyse their causes in order to reach a solution • Excellent planning&organising skills with the ability to work systematically and sequentially • Personal effectiveness and the ability to work in a pressurised environment • Maintain good relationships with colleagues and customers • The ability to adapt working hours, key outcomes, and competencies in response to the business needs which may change from time to time in response to strategies and operational requirements Details: Area: Parow, Cape Town Contract Type: Permanent Applications Close: 04 June 2024 Please indicate in your application that you are applying for the above-mentioned position. If you have not received a response within one month, your application was most likely unsuccessful. TASK reserves the right to withdraw this advertisement and not fill the above-mentioned vacancy at any stage during the recruitment process. Meeting our employment equity goals will be acknowledged during the recruitment process. By responding to this advert and sending your cv, cover letter and/or any other documentation, you are consenting to TASK processing your personal information as contained in the furnished documents. TASK may process your personal information for recruitment purposes for suitable posts that may arise within the organisation. You agree that you have familiarised yourself with South Africa’s Protection of Personal Information Act and understand your rights and obligations under this Act. #J-18808-Ljbffr