Associate Director Statistical Programmer

Job description

Statistical programming sits at the heart of clinical evidence generation — and in this role, you will be instrumental in turning complex data into the high-quality deliverables that advance medicines from development to patients. As a Statistical Programmer at the Senior or Principal level, you will contribute to and lead statistical programming activities across one or more clinical trials and global project sub-tasks within clinical development programs. Working within a matrix organization and under the oversight of a Project Statistical Programmer, you will coordinate programming workstreams, provide oversight of Contract Research Organization (CRO) activities, and ensure the timely, accurate delivery of analysis datasets and outputs in line with regulatory standards. You will apply and deepen your expertise in CDISC SDTM and ADaM standards, contribute to integrated databases and submission-ready deliverables, and bring a proactive, solutions-oriented mindset to complex technical and operational challenges. Beyond project delivery, you will play an active role in advancing best practices and process improvements within the global Biostatistics function — sharing knowledge, guiding colleagues, and helping to shape the programming standards that underpin the organization’s clinical pipeline. Who You Are: You hold a Bachelor’s or Master’s degree in a numerate discipline — such as Statistics, Mathematics, or Computer Science — or equivalent professional experience. Location - Bangalore OR Hyderabad You bring 8+ years of directly relevant statistical programming experience within clinical development at a pharmaceutical, biopharmaceutical, or CRO environment. You have hands-on experience working with SDTM datasets and creating ADaM datasets and specifications — and at the more senior level, integrated databases for regulatory submissions. You are very proficient in R and demonstrate solid knowledge of ICH and CDISC SDTM and ADaM standards, with the ability to interpret and apply relevant regulatory guidance from ICH, FDA, and EMEA. You have a sound understanding of drug development processes and the interfaces between statistical programming and other clinical development functions, including familiarity with relevant therapeutic areas and regulatory submission requirements. You work effectively in international, multicultural, and cross-functional matrix teams, with strong organizational, communication, and interpersonal skills and the ability to manage multiple priorities with accuracy and attention to detail. You demonstrate leadership capability — whether coordinating programming activities, guiding colleagues on processes and regulatory requirements, or driving project commitments with composure and clear decision-making under pressure.