Skill: pharmaceutical industry , regulatory submission , regulatory , research , regulatory requirements , clinical study , clinical , clinical research , clinical development , statistical programming; Exp: 15-18 years; The Head of India SPA is responsible for leading the SPA group, through management and supervision of all statistical programmers in India. SPA is a critical leader in the advancement of Pfizers development pipeline, and the Head of India SPA leads an organization with a significant and broad impact on Pfizers portfolio and overall position in the market. This will include championship of the implementation and use of harmonized, consistent processes and excellence in SPA deliverables related to cost effective, timely and high quality datasets, tables, listings and figures in support of clinical study reports and submissions according to agreed process and performance goals. The Head of India SPA proactively manages resources in the SPA function in India and ensures effective collaborations with GBDM functions at other sites in order to ensure consistent process, high standard and full compliance to achieve optimal project support. The Head of India SPA is also a key leader of the SPA leadership team, and will play an instrumental role in creating and developing a brand new group that will become a major presence for SPA. He/she will also develop and maintain strong links with other corresponding Leads in GBDM globally, and will work to align and motivate staff behind global GBDM strategy. The role requires experience in establishing and building a large research-focused organization, the development of strong working relationships with the other departmental functions to facilitate open lines of communication regarding project priorities, and strong technical experience with a comprehensive and expert understanding of Statistical Programming and a perspective on the fields future evolution. The role has ultimate accountability for the delivery of SPA resources and services to meet goals associated with clinical study report sign-off, to ensure the critical advancement of clinical drug candidates. Primary Duties The major duties and responsibilities of the Head of India SPA may include but are not limited to the activities described below.. Leader for SPAs organization SPA across a number of clinical research projects and teams. Build a brand-new SPA departmental presence that has a strong local culture while being a fully integrated member of the worldwide SPA organization Set current and future strategy as a core member of the SPA Leadership Team Implement global programming practices and quality guidelines in compliance with regulatory requirements and Pfizer quality standards. Drive achievement of trial deliverables and submissions for SPA. Partner with Global Head to define organizational metrics and relevant Key Performance Indicators (KPIs) to drive a high performance organization Be accountable for provision and proactive management of SPA resources across projects Evaluate and select vendors providing services in clinical programming Ensure that all staff fully understand the requirements of the job and are clear regarding the SPA deliverables for their protocol/project Drive, monitor and report on implementation of worldwide programming initiatives and routine programming deliverables Ensure development and implementation of site-specific change management based on worldwide strategies and standards; and in collaboration with other local functional heads. Ensure that all SPA activities are conducted in compliance with relevant regulatory requirements and SOPs. Ensure use of approved technologies that support the business goals Build and maintain strong and meaningful linkages with the regional/national Statistical Programming community Lead the implementation of strategies to ensure successful integration of global processes enhancing speed and quality in all SPA activities. As a key leader within GBDM worldwide, develop and maintain strong links with other GBDM leaders and functional lines to share best practices, identify areas for process and technology improvements, and develop and implement strategies to address these improvement opportunities. Through strong leadership and performance-oriented culture, pro-actively identify problems on projects and help define solutions. Ensure India-based SPA colleagues work supportively within global issue escalation process to ensure open discussion and positive learning. Lead SPA staff in forming innovative options for their activities Administer and manage the India SPA group in terms of local HR issues, goals development, performance management, application of Pfizer policies / procedures and recruitment. Ensure staff are qualified to perform their duties and complete training as required by the SPA curriculum. Actively develop staff within the SPA group to enable them to realize their full potential within the organization. Training & Education Preferred MSc / MA in statistics or computer science, or equivalent education/training is required. Prior Experience Preferred Ideally at least15 years experience in programming in the pharmaceutical industry / clinical research, with at least 10 years line management or global project team leadership experience Demonstrated leadership capability and substantive experience building and leading a team responsible for clinical study reports delivery with programming responsibility Clinical development and business experience in order to have a thorough understanding of the processes associated with delivering clinical study reports, including thorough understanding of regulatory processes at a global level and experience as key player in regulatory submission efforts Recognition in peer community as being an expert in the topic, with broad understanding of the field and how it is evolving to keep Pfizer at forefront. Experience in working with vendors (CROs or FSPs) performing clinical programming Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Degree: MA (Arts)
Function: Biotech / Pharma / R&D