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When our values align, there's no limit to what we can achieve.
At Parexel , we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel , contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
At Parexel FSP people make a difference. We have a crucial mission: to prevent and cure disease by delivering important new medicines and therapies to patients in need. We achieve this important goal through the knowledge, expertise, innovation, and commitment of our employees around the world.
Parexel is currently seeking a Senior Statistical Programmer to join us in South Africa, dedicated to a single sponsor.
Picture Yourself At Parexel :
The Senior Statistical Programmer provides technical expertise for the conduct of clinical trials, acts as an internal subject matter expert in specific areas providing technical support and expert advice, and works independently to support various programing activities related to the analysis and reporting of clinical study data.
What You'll Do At Parexel :
Project Management
Ability to fill Statistical Programming Lead role on projects.
Input into and negotiate statistical programming timelines. Ensure that timelines are adhered to.
Coordinate and lead a statistical programming team to successful completion of a study within given timelines and budget.
Monitor project resourcing, project budgets, and identify changes in scope.
Coordinate project start-up activities, creation of global programs, tracking spreadsheets, and other required documentation.
Review statistical analysis plans and mock-shells.
Review database set-up specifications.
Interact with sponsors and internal stakeholders with regard to statistical programming issues.
Assist project teams in the resolution of problems encountered in the conduct of their daily work.
Statistical Programming for Assigned Projects
Use efficient programming techniques to produce/QC derived datasets (e.g. SDTM, ADaM/TLF), tables, figures, and data listings.
Produce/QC dataset specifications and other process supporting documents and submission documentation.
Ensure quality control (QC) is performed on all process and technical activities related to derived dataset, table, data listing, and figure programming in accordance with corporate quality standards, SOPs/Guidelines, ICH-GCP, and/or other international regulatory requirements.
Here are a few requirements specific to this advertised role:
Proficiency in SAS.
Proven clinical / statistical programming experience within pharmaceutical clinical development (3 years minimum).
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.
Demonstrated proficiency in analytical programming.
Excellent analytical skills.
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 to work in a team environment with clinical team members.
Strong project management skills.
Good business awareness/business development skills (including financial awareness).
Bachelor’s degree in statistics, biostatistics, mathematics, computer science or life sciences required.
Competent in written and oral English.
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. But if you live close to our office and you want to use it, you are always welcome, and we will keep the desk ready for you!
Applicants must be authorized to work in South Africa. We are unable to sponsor or take over sponsorship of an employment Visa.
