Associate Manager - Statistical Programming in Hyderabad, भारत

Job Title : Associate Manager, Statistical Programming Central ServicesLocation : Hyderabad, India (Hybrid)Job Overview :At our Fortune 500 biotech & pharmaceutical company, we use science and innovation to develop life-changing medicines for people with serious https://jobeax.com/link/QBe1ZamoJXmfvWX4 are seeking an Associate Manager, Statistical Programming - Central Services to join our Statistical Programming team, supporting integrated analysis, regulatory submissions, and clinical trial disclosure activities in a hybrid work https://jobeax.com/link/aH3dGYiK36abFw9y this role, you will deliver high-quality programming solutions, support global regulatory submissions, and advance programming processes while collaborating with project programmers, biostatisticians, clinical transparency teams, and cross-functional https://jobeax.com/link/nT37Hz7PTiet7djc position offers the opportunity to contribute to a fast-growing, science-driven organization making a significant difference to patients https://jobeax.com/link/ixgbX2njoPvswQUx Responsibilities :- Data & Output Generation: Create integrated datasets, pooled analysis datasets, reports, and programming documentation in line with established standards and processes.- Regulatory Submissions: Support the preparation and review of electronic data packages for regulatory submissions while ensuring compliance with global regulatory and industry standards.- Trial Disclosure & Transparency: Coordinate with Clinical Transparency and Trial Disclosure teams, biostatisticians, and cross-functional partners to deliver datasets and outputs required for disclosure activities.- Process & Tool Optimization: Provide technical expertise in developing tools, standard processes, and programming solutions that improve efficiency and compliance.- Troubleshooting & Quality Assurance: Troubleshoot programming, validation, and submission-related issues and support the implementation of procedures across assigned areas.- Inspection Readiness: Support inspection readiness activities and respond to programming-related inquiries during regulatory inspections.- Cross-Functional Collaboration: Collaborate effectively across project programming teams and broader functions to achieve reporting and submission https://jobeax.com/link/yIIxDsjmdIqDY7No Qualifications :Education & Experience :i. Education : MS (or BS) in Statistics, Computer Science, Mathematics, Engineering, Life Sciences, or a related quantitative discipline.ii. Work Experience : 5+ years of clinical trial data programming experience with an MS degree, or 6+ years with a BS degree.iii. Experience within the biotechnology, pharmaceutical, or health-related industry preferred.iv. Leadership : Demonstrated project and people management https://jobeax.com/link/wUUvtAW9Fjfkhdra Skills & Industry Standards :i. Programming Skills : Proficient SAS programming skills in a clinical data environment, including Base SAS, SAS/STAT, Macro, and Graph.ii. CDISC Standards : Strong expertise in CDISC standards, including SDTM, ADaM, and Define-XML.iii. Validation Tools : Proficiency with Pinnacle 21 (P21), including reviewing and troubleshooting validation reports and compliance issues.iv. Regulatory Knowledge : Proven experience supporting regulatory submissions and maintaining compliance with global standards (FDA, EMA, PMDA).v. Submission Formats : Familiarity with electronic Common Technical Document (eCTD) submission formats.vi. Additional Technical Assets : Knowledge of open-source programming languages such as R and Python is highly desirable; SAS certification is a https://jobeax.com/link/jHlj1ZpbVAi6cFBH & Interpersonal Attributes :- Excellent communication, interpersonal, collaboration, problem-solving, and organizational skills.- Strong attention to detail with a diligent, problem-solving attitude.- Proven ability to manage multiple priorities and thrive in a fast-paced environment (ref:hirist.tech)