Mid-level industry position
A career at our company is an ongoing journey of discovery: our 58,000 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.
United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.
Under the supervision of a Project Statistical Programmer, function as a Lead Statistical Programmer for one or more clinical trials and / or other global project sub tasks, across one or more clinical development programs.
• As a lead statistical programmer o Coordinate statistical programming aspects of trials or other project subtasks.
o Provide input, via Project Statistical Programmer, to project level resource and timeline planning o Delegate work to and manage assigned team members;
o Ensure delivery progresses according to desired timelines and quality, keep Project Statistical
Programmer informed, liaising regarding the need to adjust timelines or resource plans as appropriate.
o Ensure expectations are clear to any team members under own supervision, and that communication and tracking of progress is effective.
o Perform technical planning and oversight of programming to ensure efficient coding (e.g. use of standard code, code is clear and reusable) and efficient allocation of work.
o Ensure team members are aware of relevant standards and processes and comply with them.
o For tasks/trials as allocated, ensure that the planning and management of outsourced statistical programming owned deliverables are effectively performed and are conducted to sufficient quality to meet business needs, and in a timely manner. With some direction, aid the CRO with prioritization of work when necessary in order to meet business needs.
• Ensure relevant standards are applied consistently.
• With some direction ensure maximization of global integratability and interpretability of data. Coordinate with Data Management and Clinical Operation to target high quality databases and specifications at trial level as assigned.
• Work closely with colleagues in interface roles (e.g. Project Data Manager, Project Statistician), to ensure smooth and efficient running of the project.
• Without direction, efficiently perform (and direct teams to perform) complex trial and with direction project level programming tasks, from set up to project close, with all tasks to high quality and efficiency.
• Able to quickly and effectively integrate into different project teams if needed.
• Responsible for ensuring statistical programming deliverable timelines and quality expectations are met and best practices implemented. Ensures appropriate level of CRO interaction and surveillance.
• Participate in Statistical Programming / Biostatistics initiative teams as required.
• Provide expert statistical programming advice / guidance and training to trial teams as needed.
Required professional experience and necessary training
• BS or MS in a numerate discipline, preferably Statistics, or Mathematics or Computer Science
• Fluent in English (written and spoken)
• Proven success, including some coordination or leadership Statistical Programming role within clinical development at a pharmaceutical or Biotech Company, or at a CRO, equivalent to minimum of 5 years directly relevant experience. Professional experience in an international environment is beneficial.
• Good understanding of drug development , including knowledge of interfaces and interdependencies with other functions
• Good working knowledge (or ability to obtain) of applicable therapeutic areas and statistical concept and relevant regulatory and data submission guidelines.
• Experience of working with SDTM datasets and of creating ADaM datasets and specifications, including development of integrated databases. Demonstrated competence in considerations for efficient technical planning.
• Demonstrated good project management skills.
• Proficiency in SAS. Expertise in SAS/BASE, SAS/STAT, SAS/MACRO, SQL, SAS/Graph
What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!
Curious? Apply and find more information at https://jobs.vibrantm.com