Associate Director - Statistical Programming Bengaluru, Karnataka, India

The Associate Director of Statistical Programming will oversee statistical programming activities for multiple clinical studies, maintain programming infrastructure, and ensure compliance with SOPs to produce quality and timely deliverables. This role requires extensive experience and proven skills in the use of SAS within a Statistical Programming environment, along with a complete understanding of statistical programming processes, procedures, and roles. The successful candidate will support Biostatistics in statistical analysis, including generating analysis data listings, tables, and figures, and creating all files necessary to support an electronic submission in the eCTD format. Additionally, strong people management and supervisory skills are essential to provide direct line management to statistical programmers, identify training needs, and optimize staff utilization. The role also involves managing the day-to-day activities of external partners in delivering program deliverables.

Accountabilities

• Serve as the Lead Programmer and Manager of the statistical programming efforts.
• Develop and validate technical programming specifications for analysis datasets using Alexion or ADaM standards.
• Independently develop and validate programs that generate analysis datasets based on Alexion or ADaM specifications.
• Develop and validate technical programming specifications for protocol-specific efficacy tables, listings, figures/graphs.
• Independently develop and validate programs that generate protocol-specific efficacy tables, listings, figures/graphs using Alexion specifications.
• Ensure that the filing of study documentation is maintained to the standard required according to processes and acceptable for audit.
• Directly support the Clinical and Statistical Programming Director in all aspects of the management and development of the Statistical Programming team.
• Participate in the ongoing review of the processes used by the Statistical Programming group to ensure processes are continually complied with and updated as necessary.
• Create and/or review programming plans, and ensure appropriate resource allocation and prioritization.
• Act as the primary department contact to ensure that department standards are implemented in all studies.
• Manage adherence to all company policies, SOPs, and other controlled documents; ensure all programming activities adhere to departmental standards.
• Collaborate closely with Biostatistics, Clinical Data Management, Pharmacovigilance, Clinical Operations, and other functions within Alexion to address their needs for programming support.

Essential Skills/Experience

Desirable Skills/Experience

At AstraZeneca's Alexion division, we are driven by our passion for making a difference in the lives of patients with rare diseases. Our unique approach combines the agility of a biotech with the resources of a global biopharma leader. We foster an inclusive culture where innovation thrives, empowering our employees to grow both personally and professionally. Join us to be part of a team that is dedicated to transforming lives through groundbreaking science and compassionate care.

Ready to make an impact? Apply now!