Explore senior manager, statistical programming jobs and discover a pivotal leadership role at the intersection of data science, clinical research, and regulatory strategy. This senior-level position is critical within the pharmaceutical, biotechnology, and clinical research industries, where professionals lead teams responsible for transforming complex clinical trial data into robust, submission-ready evidence for global health authorities. Individuals in these roles are strategic partners who ensure the integrity, accuracy, and regulatory compliance of all statistical programming outputs that underpin drug development and approval. A Senior Manager of Statistical Programming typically oversees the entire statistical programming lifecycle for a portfolio of clinical studies or a therapeutic area. Common responsibilities include developing and implementing departmental strategies, standards, and processes to enhance efficiency and quality. They manage internal programming teams and often oversee the work of Contract Research Organizations (CROs), ensuring external deliverables meet stringent internal and regulatory standards. A core aspect of the role is the hands-on management and validation of analysis datasets and outputs. This includes ensuring all programming aligns with CDISC standards (such as SDTM and ADaM), which are mandatory for electronic submissions to agencies like the FDA and EMA. They review key documents like Statistical Analysis Plans (SAP) and table shells, and lead the creation of Tables, Listings, and Figures (TLFs) for clinical study reports and regulatory submissions. Furthermore, they provide expert programming support for ad-hoc analyses and data explorations, partnering closely with Biostatisticians, Data Management, and Clinical Development teams. The typical skill set and requirements for these leadership jobs are extensive. Candidates generally possess an advanced degree (MS or PhD) in Statistics, Biostatistics, Computer Science, or a related life science field. A minimum of 8-12 years of progressive experience in statistical programming within the pharma/biotech sector is standard, with substantial direct experience in regulatory submissions (NDA/BLA). Mastery of SAS programming (Base, Macro, STAT, GRAPH) is fundamental, though knowledge of R is increasingly valued. In-depth, practical knowledge of CDISC standards is non-negotiable. Beyond technical prowess, successful senior managers demonstrate proven leadership and mentorship abilities, excellent project management and vendor oversight skills, and superior communication to bridge technical and non-technical stakeholders. A firm understanding of ICH guidelines, GCP, and global regulatory requirements completes the profile for this high-impact career. For those seeking to advance into a role that blends deep technical expertise with strategic leadership and direct influence on bringing new therapies to patients, senior manager, statistical programming jobs represent a premier career destination. This profession offers the opportunity to build and guide high-performing teams while ensuring the scientific rigor and compliance of the data that shapes modern medicine.
