Statistical Programmer I / II with Oncology experience, FSP

As a Statistical Programmer II at Parexel, you will provide technical expertise for the conduct of clinical trials, and work with minimal supervision to support various programming activities related to the analysis and reporting of clinical study data. In addition, as a Statistical Programmer II, you may fill the Statistical Programming Lead role (or part of that role) on small, non-complex projects.

Day to day Responsibilities in this Role include;

• Create SAS programs to generate derived analysis datasets and content for tables, listings, and figures; Perform programming validation to ensure quality of analysis datasets and programming outputs

• Provides programming support for project teams, including development of programming strategies, standards, specifications and programmed analysis

• Support the electronic submission preparation and review

• Reviews key planning documents (e.g., statistical analysis plan, data presentation plan, data review plan) to ensure alignment with development team objectives and clarity and completeness of programming assumptions and requirements; Assesses impact on programming activities

• Interacts with vendors regarding project standards, programming conventions, programming specifications and file transfers

• Provides leadership for ensuring quality of Global Biometric and Data Sciences (GBDS) deliverables by consistently applying standards and complying with regulatory requirements, guidance and corporate and departmental SOPs and work practices

• Identifies opportunities for increased efficiency and consistency within GBDS and our interactions with strategic vendors

• Independently leads and / or performs programming assignments with minimal supervision

• Support improvement initiatives

What do you need to have to qualify for this role?

Knowledge and Experience:

• Sound SAS programming skills (Clinical Programming), with a minimum of 3 -5 years experience within Clinical Research - supporting regulatory filings (e.g. NDA, BLA, MAA) . Oncology therapeutic area exp will be a strong advantage.
• Experience with; ADaM, TLF is essential
• Knowledge of the drug development process, clinical trial methodology, statistics and familiarity with global regulatory requirements
• Experience in other software packages (e.g. R)
• Experience with the Linux operating system

Education:

• Educated to degree level in a relevant discipline and/or equivalent work experience. Bachelor’s degree in statistics, biostatistics, mathematics, computer science or life sciences required.

Skills:

• Excellent analytical skills.
• Demonstrated proficiency in analytical programming
• Have in-depth understanding of clinical data structure (e.g. CDISC standards) and relational database.
• Demonstrated skills in using software tools and applications, e.g., MS office, XML, Pinnacle 21.
• Demonstrated ability in the handling and processing of upstream data, e.g., multiple data forms, workflow, eDC, SDTM.
• Demonstrated ability in providing outputs to meet downstream requirements, e.g., ADaM, Data Definition Table, e-submission.
• Have good understanding of regulatory, industry, and technology standards and requirements.
• Have good knowledge of statistical terminology, clinical tests, medical terminology and protocol designs.
• Demonstrated ability to work in a team environment with clinical team members.
• Proficiency in SAS.
• Knowledge and understanding of the programming and reporting process.
• Knowledge of SOPs/Guidelines, ICH-GCP, and any other applicable local and international regulations such as 21 CFR Part 11.
• Competent in written and oral English.
• Good communication skills.
• Ability to learn new systems and function in an evolving technical environment.
• Ability to manage competing priorities and flexibility to change.
• Attention to detail.
• Ability to successfully work as part of a global team.
• Work effectively in a quality-focused environment.
• Effective time management in order to meet daily metrics or team objectives.
• Show commitment to and perform consistently high quality work.
• Business/operational skills that include customer focus, commitment to quality management, and problem solving.

A little about us:

Highly qualified and dynamic team. Multinational working environment. Smooth induction and training program.  We offer competitive financial packages, training, and development. Expect exciting professional challenges but with a healthy work/life balance. We value your welfare just as highly as that of our patients.

Parexel has a fully flexible work arrangement - you can be fully home based, however if you live close to our Bloemfontein office and you want to use it, great, you are always welcome, and we will keep the desk ready for you!

Applicants must be authorized to work in South Africa as we are unable to sponsor or take over sponsorship of an employment Visa.