FDA Submissions Jobs in Thane

Job Title: Statistical Programmer Key Responsibilities: Develop SAS programs to generate derived analysis datasets and produce content for tables, listings, and figures (TLFs). Validate programming outputs to ensure the quality and accuracy of analysis datasets. Provide programming support to project teams by developing programming strategies, standards, specifications, and executing programmed analysis. Assist in the preparation and review of electronic submissions. Review key planning documents (e.g., statistical analysis plan, data presentation plan, data review plan) to ensure alignment with project objectives and clarity in programming assumptions and requirements. Assess the impact of these documents on programming tasks. Collaborate with vendors to establish project standards, programming conventions, and manage programming specifications and file transfers. Lead the effort to ensure the quality of Global Biometric and Data Sciences (GBDS) deliverables, applying standards consistently and adhering to regulatory guidelines, corporate SOPs, and departmental work practices. Identify opportunities for enhancing efficiency and consistency within GBDS and improve interactions with strategic vendors. Independently manage and perform programming tasks with minimal supervision. Contribute to continuous improvement initiatives to optimize workflows and outputs. Minimum Qualifications: Bachelor s degree in Statistics, Biostatistics, Mathematics, Computer Science, Life Sciences, or a related field. At least 3 years of programming experience in a relevant industry. For US-based positions, US military experience will be considered as part of industry experience. Proficiency in using SAS, R, or other programming languages to create derived analysis datasets and TFLs. Strong understanding of clinical data structures (e.g., CDISC standards) and relational databases. Proficiency in software tools such as MS Office and XML. Experience in handling and processing upstream clinical data (e.g., multiple data forms, eDC, SDTM). Ability to produce outputs that meet downstream requirements (e.g., ADaM, Data Definition Table, e-submission). In-depth knowledge of regulatory, industry, and technology standards and requirements. Familiarity with statistical terminology, clinical tests, medical terminology, and protocol designs. Demonstrated ability to collaborate within a team environment alongside clinical team members. Preferred Qualifications: A minimum of 3 years of experience in clinical/statistical programming within pharmaceutical clinical development. Knowledge of the drug development process, clinical trial methodology, and familiarity with global regulatory requirements. Experience using other software packages (e.g., R). Familiarity with the Linux operating system. Qualification : Bachelors degree in Statistics, Biostatistics, Mathematics, Computer Science, Life Sciences, or a related field.