Director Therapy Area Head, Statistical Programming

Who we are

Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.

The opportunity

The Director, Statistical programming TA Head, provides strategic and technical leadership for programming deliverables within a therapeutic area. This role is accountable for high-quality and efficient delivery of statistical programming deliverables within a therapeutic area. As a leader, the Director defines delivery strategies, anticipates and mitigates risks, fosters innovation in programming technologies and processes, forecasts and maintains budget. This position will be a key partner to Therapy Area Head, Statistics and ensures successful implementation of statistical programming strategies and efficient execution of programming deliverables within the therapeutic area. The role also includes functional management responsibilities such as talent development, recruitment, and coaching, ensuring a skilled and motivated global programming team.

How you’ll spend your day

• Provide strategic leadership for programming deliverables across a disease area, or therapeutic area.
• Define and implement programming strategies that enable high-quality, efficient, and compliant outputs for regulatory submissions and clinical trial reporting.
• Lead and develop global programming teams, including direct reports, contingent staff, and vendors
• Partner with cross-functional stakeholders (Statistics, Data Management, Clinical Development, Regulatory) to ensure alignment and successful execution of programming deliverables, Sets tasks and prioritization within a disease area, or therapeutic area.
• Delivers comprehensive programming leadership to clinical project teams and vendors, driving the implementation of standards, specifications, and analyses in compliance with regulatory expectations, SOPs, and organizational practices.
• Drives innovation and continuous improvement projects within programming, challenges status-quo, implements innovative strategies and technologies for clinical trial programming within the therapeutic area.
• Contributes to other department initiatives. 
• Provide training, mentorship, and coaching to build a high-performing programming workforce.
• Drives the recruitment and retention strategies for Statistical Programming within a TA, in collaboration with Statistical Programming LT, HR and Talent Acquisition teams
• Manage budgets, forecasts, and resource allocations effectively to meet organizational priorities within a TA.
• Ensures that SOPs and guidelines are followed, and the clinical programming processes are well known by all teams within the TA.
• Keep abreast of industry programming and technological advancements.
• Member of Statistical Programming Leadership Team, and member of Extended GSD Leadership team, in shaping up the function and department vision.

Your experience and qualifications

• Bachelor’s Degree/Master’s Degree/PhD in Science, Statistics, Information Technology or equivalent combination of education and related work experience is required. 
• A minimum of 10 years of experience in a pharmaceutical or clinical research setting as a programmer. 
• Expert knowledge of the drug development process, clinical trial methodology, regulatory requirements, industry standards, statistical principles, and medical terminology relevant to data analysis and submission.
• Proven ability to attract, develop, and retain top talent.
• Proven ability to influence clinical programming processes.
• Demonstrated success in leading business process transformations, driving organizational culture change, and advancing programming expertise on complex programs.
• Directed programming teams through numerous successful submissions and approvals in key global markets.
• Serves as the subject matter expert in all aspects of Clinical Programming. Initiates and leads multi-disciplinary pivotal projects to improve operational processes related to Clinical Trials execution and Data Presentation. Provides development plan for efficiency of programming processes and systems.
• Active member of professional industry organizations and contributor/presenter at scientific