Clinical Statistician

**Overall Purpose of the Position**:
As part of our growing Data Management (DM) team, the position is typically responsible for developing statistical methods and sections of protocols; preparing statistical analysis plans and writing detailed specifications and communicating with clients and other internal and external stakeholders. The position is also accountable for controlling costs, maximizing revenue and providing training and support to staff.

The role is varied, working with different sponsors across several therapeutic areas within phases I-IV of clinical trials. 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**:

- Preparing statistical analysis plans (SAP) and writing detailed specifications for analysis files, tables, listings, and figures
- Advising on study/protocol design and power calculations
- Interpreting analyses and writing statistical sections of study reports
- Offering clear, user-friendly interpretations and explanations to colleagues and customers
- Providing training, guidance, and mentorship to less experienced and new staff
- Planning, executing and overseeing all SAP activities on a study, including but not limited to, resource estimation, working within budget, meeting timelines, maximizing quality, interaction with other departments and the client, etc
- Supporting the development and maintenance of SAS or R programs within the DM team to create SDTM and ADaM datasets and TFLs, and perform quality control (QC) of SDTM, ADaMs and TFLs
- Producing Define XML / PDFs, Analysis Results Metadata (ARM), and Reviewers Guides to support SDTMs and ADaMs
- Developing specifications for SDTMs and ADaM datasets
- Responding to QA and client audits, and supporting qualification audits
- Identifying processes within programming that will increase productivity, quality, and efficiency

**Ideal Requirements**
- Minimum of an MSC in statistics or biostatistics
- Previous experience working as a Lead Statistical Programmer in either a biotech, CRO or pharma company using SAS/R
- Familiarity with drafting SAP
- Knowledge and understanding of the Analysis Data Model (ADaM) Guidelines
- Experience in working with clients as a project or statistical lead, alternatively you should have an equivalent combination of education, training, and experience
- Knowledge of ICH-GCP with a strong interest in clinical research
- Professional use of the English language; both written and verbal
- Clinical trial systems knowledge e.g., CDISC SDTM
- Data management skills and experience
- 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 and a key attention to detail
- Ability to anticipate problems and resolve problems before they occur
- Recognise recurring issues and analyse their causes to reach a solution
- Excellent planning and 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

**Area**: Parow, Cape Town

**Contract Type**: Permanent

**Applications Close**:02 April 2024

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

**Job Types**: Full-time, Permanent

Application Question(s):

- Do you have advanced computer skills?
- Do you have experience as a Lead Statistical Programmer in either a biotech, CRO or pharma company using SAS/R?

**Education**:

- Masters (required)

Application Deadline: 2024/04/02