Manager - Statistical Programming

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 a Manager, Statistical Programming Central Services to join our Statistical Programming team, supporting our Central Services function in a hybrid work model.
In this role, you will lead statistical programming activities across integrated data and reporting, regulatory submissions, exploratory analyses, and clinical trial disclosure while collaborating with Statistical Programming, Biostatistics, Clinical Transparency and Trial Disclosure, and cross-functional teams. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

Key Responsibilities

• Leadership & Deliverables: Lead programming support for integrated datasets, pooled analyses, and reporting deliverables across assigned projects.
  
• Documentation & Standards: Create and maintain programming documentation, including integrated dataset specifications such as pooled ADaM datasets, following established standards and processes.
  
• Regulatory Submissions: Support the creation and review of electronic data packages for regulatory submissions to ensure compliance with regulatory, industry, and internal standards.
  
• Trial Disclosure & Transparency: Coordinate with Clinical Transparency and Trial Disclosure, Biostatistics, Statistical Programming, and cross-functional teams to deliver disclosure-ready datasets and outputs.
  
• Process & Tool Optimization: Provide technical expertise in developing tools, standard processes, and programming solutions that improve efficiency and compliance.
  
• Issue Resolution & Inspection Readiness: Troubleshoot and resolve complex programming and submission-related issues while supporting inspection readiness activities and regulatory inquiries.
  
• Cross-Functional Collaboration: Collaborate effectively across teams to achieve submission and reporting objectives in a highly regulated environment.
  
• Team Mentorship: Guide and support team members in developing their technical skills and knowledge of submission programming.
  

Candidate Qualifications

Education & Experience

• Education: MS or BS in Statistics, Computer Science, Mathematics, Engineering, Life Sciences, or a related field.
  
• Work Experience: 7+ years of statistical programming experience, preferably processing clinical trial data within the biotechnology, pharmaceutical, or health-related industry.
  
• Leadership Experience: Proven experience with project and people management, including leading teams and managing deliverables. (Mandatory)
  

Technical Skills & Industry Standards

• Programming Expertise: Proficient SAS programming skills in a clinical data environment (SAS Base, SAS/STAT, Macro, and Graph) with expertise in at least one, preferably multiple, therapeutic areas.
  
• CDISC Standards: Strong understanding of CDISC standards, including Study Data Tabulation Model (SDTM), Analysis Data Model (ADaM), and Define-XML.
  
• Validation & Submissions: Proficiency with Pinnacle 21 (P21), including experience reviewing and troubleshooting P21 reports and compliance issues. Good knowledge of electronic Common Technical Document (eCTD) submission formats.
  
• Regulatory Knowledge: Proven experience in regulatory submissions and compliance with global standards, including FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), and CDISC requirements.
  
• Preferred Qualifications: SAS certification is a plus; knowledge of open-source programming languages such as R and/or Python is a plus.
  

Professional & Interpersonal Skills

• Strong problem-solving skills with the ability to handle complex technical and programming challenges.
  
• Excellent communication and interpersonal skills, with the ability to collaborate across functional areas.
  
• Strong attention to detail and the ability to manage multiple priorities in a fast-paced environment.