Sr SAS Programmer - Clinical Research

Brief Description about the Job

- Multi-discipline role, with focus on delivering:

- Project leadership of assigned complex/multiple projects and/or

- Line management of assigned personnel and/or

- Technical expertise and leadership in support of Programming deliveries, projects, initiatives, and training development of Programming personnel.

- Lead process improvement and knowledge-sharing within the function.

- Provide advanced project, technical, or line management support in the preparation and review of high quality programming deliverables and documentation, as well as the processes and standards required, to both colleagues and clients.

- Ensure consistently high levels of customer care are provided.

- Deliver excellent customer care in support of genuine value and a great customer experience.

- Comprehensive knowledge of clinical and pharmaceutical drug development and associated ICH/GCP guidelines.

- Comprehensive knowledge of pharmaceutical industry standards.

- Standard operating procedures (SOPs) and processes, as well as applicable regulatory requirements and/or guidelines on behalf of the client.

- Ensure adherence to all relevant SOPs, guidelines and processes.

- Maintain up-to-date knowledge of the external regulatory environment relating to programming, including ICH/GCP requirements, and provide advice and educate colleagues (and clients) on changes to regulatory requirements and/or other guidelines relating to programming.

- Provide high quality deliverables and appropriate communication within expected timelines and budget.

- Use acquired in-depth knowledge and broad expertise to enhance procedures within Programming.

- Provide mentoring and leadership, as required.

- Ability to lead teams on complex projects, locally or globally, as required.

- Ability to critically review and provide comments on clinical documents, e.g. protocol, CRF and SAP.

- Ability to perform Peer Review and Final Inspection.

- Ability to represent the company at external conferences and forums.

- Participate in meetings such as recruitment, business development and audits from a clinical programming perspective.

- Perform other reasonable tasks as requested by management.

- Assist with the implementation of and follow Project Management procedures.

- Advanced/expert programming experience covering activities from study set-up to final reporting.

Technical Lead Role

- Demonstrated SAS programming knowledge to an expert level.

- Ability to work independently as a programmer and advise on preferred

- Programming solutions for complex projects.

- Provide programming expertise internally and externally on complex clinical projects.

- Delivery of consistently high quality output in a timely manner.

- Ability to identify departmental technical training requirements.

- Develop and deliver SAS training and workshops and other programming related training sessions, as applicable.

- Continuous acquirement of SAS and other appropriate programming expertise within pharmaceutical industry.

Project Lead Role

- Comprehensive knowledge of regulatory agency guidelines.

- Ability to plan resource requirements and project timelines, and recognise project training needs, including multiple/complex projects.

- Ability to establish and enforce the appropriate standards for multiple projects.

- Pro-actively address changing timelines, priorities and resourcing requirements in line with appropriate issue escalation processes.

- Ability to delegate work appropriately and monitor project progress.

Line Management Role

- Responsible for the line management of up to 6 staff.

- Perform an active role in the development of direct reports and/or provide training, mentorship and support for programmers as necessary.

- Approve the timesheets of direct reports and review the timesheet entries which impact functional Key Performance Indicators.

- Supervision of direct reports through fortnightly or monthly meetings (as a minimum) and provision of day-to-day support on an informal ongoing basis, as required.

- Perform annual and interim reviews in accordance with HR processes and SOPs for direct reports.

- Implementation of all processes applicable to the role of a Line Manager.

- Responsible for monitoring team resource allocation and billability to maximise Key Performance Indicators.

Position Specific Experience

- Knowledge and experience on pharmaceutical industry and requirements for delivery of clinical trials.

- Programming experience covering activities from study set-up to final reporting

Position Success Factors

- Should have PC skills, excellent knowledge of statistical software packages (particularly SAS), excellent organisational skills, excellent English communication skills (oral and written), and excellent analytical skills.

- Has a proven ability to lead and work with teams.

- Has continuous improvement mentality and an excellent attention to detail.

Contact Person: Manisha // Latha
Contact No: 9845699450 // 09980907023