Principal Programmer/Associate Manager - Statistical Programming, Cent

Associate Manager, Statistical Programming Central Services

Location: 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 diseases. We 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 model.
In 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 partners. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a significant difference to patients worldwide.

Key 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 objectives.
  

Candidate Qualifications

Education & Experience

• Education: MS (or BS) in Statistics, Computer Science, Mathematics, Engineering, Life Sciences, or a related quantitative discipline.
  
• Work Experience:
  
• 5+ years of clinical trial data programming experience with an MS degree, or 6+ years with a BS degree.
  
• Experience within the biotechnology, pharmaceutical, or health-related industry preferred.
  
• Leadership: Demonstrated project and people management experience.
  

Technical Skills & Industry Standards

• Programming Skills: Proficient SAS programming skills in a clinical data environment, including Base SAS, SAS/STAT, Macro, and Graph.
  
• CDISC Standards: Strong expertise in CDISC standards, including SDTM, ADaM, and Define-XML.
  
• Validation Tools: Proficiency with Pinnacle 21 (P21), including reviewing and troubleshooting validation reports and compliance issues.
  
• Regulatory Knowledge: Proven experience supporting regulatory submissions and maintaining compliance with global standards (FDA, EMA, PMDA).
  
• Submission Formats: Familiarity with electronic Common Technical Document (eCTD) submission formats.
  
• Additional Technical Assets: Knowledge of open-source programming languages such as R and Python is highly desirable; SAS certification is a plus.
  

Professional & 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.