Quanticate - Senior Statistical Programming Project Manager

Responsibilities:

- 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

- Provide high-quality, timely support that conforms to current Quanticate and client-specific standard operating procedures (SOPs) and processes, as well as applicable regulatory requirements and/or guidelines on behalf of the client

- Provide mentoring and leadership, as required

- Lead teams on complex projects, locally or globally, as required

- Critically review and provide comments on clinical documents, e.g. protocol, CRF and SAP

- Perform Peer Review and Final Inspection

- Represent the company at external conferences and forums

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

- Provide programming expertise internally and externally on complex clinical projects

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

- Responsible for the line management of up to 6 staff

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

- Support recruitment and retention of staff within Quanticate.

Qualifications:

- Qualified to degree level or equivalent, preferably in a numerate discipline and/or have an understanding of basic statistics

- Extensive programming experience preferably within the pharmaceutical industry or medical sector

- Knowledge and experience of the pharmaceutical industry standards and requirements for the delivery of clinical trials

- Clinical programming experience covering activities from study set-up to final reporting

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

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

- A proven ability to lead and manage teams

- Has continuous improvement mentality and an excellent attention to detail

- Have a good understanding of ICH/GCP guidelines

- Good organisational, communication (oral and written), and analytical skills.

Company:

An exciting opportunity for a Senior SAS Programmer II has arisen within our Clinical Research Organisation (CRO), Quanticate. Working from our Bangalore, India office, you will work within Quanticate's global programming department, providing the highest quality statistical programming services to our pharmaceutical, biotechnology, nutritional and medical device clients.

Having formed in 2007, from the merger of two specialist Biometrics CROs, Quanticate has grown to become the world's largest CRO specialising in the provision of data-related services. Our services include Clinical Data Management, Biostatistics, Clinical Programming, Medical Writing and Pharmacovigilance.

As a recognised "Investors in People" employer, Quanticate is committed to the development of its employees. With structured career paths across each of its functional areas, and Junior and Expert Academies that have been created to help fast-track you up the CRO career ladder, you will be working for a company that is able to provide long-term career development opportunities alongside flexible working arrangements.

The Programming Group

With approximately 100 SAS Programmers spread across each of our global offices, the Programming Group is Quanticate's largest department. The UK and US teams report to a Senior Director of Programming based in the UK, and the ROW teams i.e. Poland, India and South Africa, report to a Senior Director of Programmer based in Poland.

As a Senior SAS Programmer II, you will report directly to a Principal Programmer who, in turn, reports to one of the Senior Directors of Programming.

Summary:

This is a fantastic opportunity to further develop a SAS programming career within a CRO that specialises in data-related services. You will receive substantial and targeted training that will assist in your continued career development within clinical SAS programming. You will have the opportunity to work as part of global project teams, gaining exposure to high profile, global studies for major pharmaceutical clients.

Subramanyam.Katperi
Internal Resourcing Specialist- Quanticate-India
+91-9000090203