D&I AIN Director

<h2><b>Career Category</b></h2>Research<h2></h2><h2><b>Job Description</b></h2><p><b>Director, Design &amp; Innovation</b></p><p><b>What you will do</b></p><p>Amgen is expanding its global Biostatistics capabilities, with Amgen India (AIN) playing a key role in integrated delivery and functional leadership. The Director, Design &amp; Innovation provides strategic, operational, and people leadership for Design &amp; Innovation capabilities based in Amgen India. This role is accountable for building, managing, and scaling India-based teams across Biomedical Data Stewardship (BMDS), Centralized Statistical Monitoring (CSM), Safety Statistics (SS), and Global Randomization &amp; Blinding (GRB).</p><p></p><p>The position serves as the primary India-based leadership interface to global Design &amp; Innovation leaders as well as cross-functional AIN senior leadership stakeholders within and outside of CfDA AIN, ensuring alignment to global strategy while enabling efficient, high-quality execution and capability growth at AIN. While not all functions may be fully represented in India initially, this role is responsible for planning and supporting the expansion of Design &amp; Innovation presence over time.</p><p></p><p><b>Accountabilities:</b></p><ul><li>Provides leadership for Design &amp; Innovation functions based in India, ensuring delivery of high-quality, compliant, and value-added outputs aligned with global standards and strategy.</li><li>Serves as the primary people leader and managerial owner for India-based staff across BMDS, CSM, SS, and GRB.</li><li>Acts as a strategic partner to global Design &amp; Innovation leaders, supporting execution of the global vision while representing India capabilities, capacity, and growth opportunities.</li><li>Drives adoption of innovative design, statistical, data stewardship, centralized statistical monitoring, safety monitoring, and randomization/blinding approaches in collaboration with global function heads.</li><li>Ensures consistent application of Amgen policies, SOPs, and controlled documents across all India-based Design &amp; Innovation activities.</li><li>Supports capability development, talent pipeline growth, and succession planning for Design &amp; Innovation functions in India.</li><li>Provides oversight of resourcing, prioritization, and workload balancing across India-based teams.</li></ul><p></p><p>This position is currently located at Amgen India (Hyderabad).</p><p></p><p><b>Responsibilities:</b></p><p><b>Strategic &amp; Operational Leadership</b></p><ul><li>Translate global Design &amp; Innovation strategy into executable plans for India-based teams.</li><li>Support delivery of innovative statistical methodologies, data standards, centralized statistical monitoring, safety monitoring, and randomization/blinding services.</li><li>Partner with global leaders to identify opportunities for expanding Design &amp; Innovation capabilities and scope at AIN.</li><li>Ensure operational excellence, quality, and regulatory compliance across all supported functions.</li></ul><p><b>People Leadership &amp; Talent Development</b></p><ul><li>Recruit, develop, coach, and retain high-performing Design &amp; Innovation staff in India.</li><li>Build a strong leadership bench across BMDS, CSM, SS, and GRB in alignment with future-state organizational needs.</li><li>Foster a collaborative, inclusive, and high-accountability culture consistent with Amgen values.</li><li>Oversee performance management, development planning, and career progression for direct reports.</li></ul><p><b>Cross-Functional &amp; Global Collaboration</b></p><ul><li>Act as the primary liaison between India-based Design &amp; Innovation and CfDA teams and global counterparts.</li><li>Collaborate with Development Therapeutic Areas, Global Biostatistics, Global Patient Safety, Dev IS, CfOR, PMED, and other partners as needed.</li><li>Support global and local AIN initiatives related to innovation, process improvement, technology adoption, and standards implementation.</li></ul><p><b>Governance, Quality &amp; Compliance</b></p><ul><li>Ensure adherence to regulatory expectations, internal controls, and quality standards.</li><li>Support development, review, and implementation of policies, SOPs, and standards relevant to Design &amp; Innovation activities.</li><li>Participate in audits, inspections, and quality reviews as required.</li></ul><p></p><p><b><span>What we expect of you</span></b></p><p>We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a strategic Biostatistics leader with a passion for tech-enabled transformation.</p><p></p><p><b><u>Basic Qualifications</u></b></p><ul><li>Master’s degree or higher in Statistics, Biostatistics, Computer Science, Mathematics, Life Sciences, or related scientific discipline</li><li>At least 8 years of experience in the pharmaceutical, biotechnology, or medical research industry.</li><li>Demonstrated experience in people management, including direct reports.</li><li>Strong written and verbal English communication skills.</li><li>Experience working effectively in a globally distributed, cross-cultural environment.</li></ul><p></p><p><b><u>Preferred Qualifications</u></b></p><ul><li>Doctorate degree in Statistics, Biostatistics, or related field.</li><li>Experience across one or more of the following domains: statistical innovation, data stewardship, safety statistics, centralized statistical monitoring, or randomization and blinding.</li><li>Working knowledge of drug development across multiple phases.</li><li>Experience with regulatory submissions and interactions.</li><li>Demonstrated success leading multidisciplinary teams in a matrixed organization.</li><li>Experience driving innovation, process improvement, or capability build-out.</li><li>Experience developing or implementing policies, SOPs, and standards.</li><li>Budget, resource planning, and vendor oversight experience.</li><li>External visibility through industry groups, forums, or professional organizations (nice to have, not mandatory).</li></ul><p></p><p><b>Competencies:</b></p><p><b>Scientific / Technical Leadership</b></p><ul><li>Strong foundational understanding of clinical statistical principles, and/or clinical data standards.</li><li>Ability to guide and challenge teams on fit-for-purpose approaches without needing to be the deepest technical expert in every area.</li><li>Appreciation for innovative methods and emerging industry trends.</li></ul><p><b>People &amp; Organizational Leadership</b></p><ul><li>Proven ability to lead, develop, and motivate diverse teams.</li><li>Strong coaching mindset with a track record of growing talent.</li><li>Comfortable leading through influence in a matrixed, global environment.</li></ul><p><b>Business Acumen &amp; Strategic Thinking</b></p><ul><li>Understands how Design &amp; Innovation capabilities support broader development and business objectives.</li><li>Able to balance innovation, quality, speed, and operational efficiency.</li><li>Sound judgment in prioritization and resource allocation.</li></ul><p><b>Communication &amp; Influence</b></p><ul><li>Communicates complex topics clearly and credibly to varied audiences.</li><li>Builds trust and effective partnerships across functions and geographies.</li><li>Able to influence without formal authority.</li></ul><p></p><p><b><span>What you can expect of us</span></b></p><p>As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being.</p><ul><li>Vast opportunities to learn and develop within our global organization</li><li>Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act</li><li>Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits</li></ul><p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p>.