02 Aug
|
Clymb Clinical
|
India
02 Aug
Clymb Clinical
India
Mumbai, India
About
The Head of Statistical Programming Operations – India will establish and scale Clymb’s offshore statistical programming, automation, and data analytics organization. This role will lead a high-performing India-based delivery team, drive operational excellence, embed automation and innovation into programming workflows, and ensure high-quality, submission-ready deliverables for global clients. The role partners closely with global leadership to ensure standardized processes, efficient resourcing, and continuous improvement.
Responsibilities
Offshore Operations & Delivery
- o Build and scale offshore statistical programming and analytics operations in India.
- o Define delivery models, governance, and engagement frameworks aligned with global teams.
- o Lead, mentor, and grow teams of SAS programmers, statisticians, data scientists, and automation specialists.
- o Oversee delivery of SDTM, ADaM, TLFs, and regulatory submission outputs, ensuring compliance with CDISC standards and regulatory requirements.
- o Serve as the senior escalation point for complex technical or delivery issues.
Automation, Quality & Standards
- o Drive adoption of automation, reusable assets, standard libraries, and AI-assisted programming.
- o Implement and maintain SOPs, programming standards, and best practices across offshore delivery.
- o Monitor quality, productivity,
and delivery KPIs; lead continuous improvement initiatives.
Client, Stakeholder & Strategic Leadership
- o Act as a senior client-facing leader for offshore operations and delivery discussions.
- o Support business development through operational input, solution design, and resourcing strategies.
- o Contribute to Clymb’s biometrics and technology strategy, identifying opportunities to expand services through offshore scale and innovation.
Required qualifications
- o Bachelor’s degree (or higher) in Statistics, Biostatistics, Computer Science, or a related field.
- o 12+ years of statistical/clinical programming experience in the life sciences industry.
- o Proven experience building and leading offshore or global delivery teams.
- o Strong expertise in SAS, macros, programming automation, and CDISC SDTM/ADaM.
- o Direct experience supporting regulatory submissions (NDA/BLA/MAA/PMDA).
- o Solid leadership, communication, and stakeholder management skills.
Preferred qualifications
- o Experience with AI-assisted programming, advanced automation, or analytics platforms.
- o Multi-therapeutic area experience.
- o Prior client-facing leadership role in a CRO or consulting environment.
Position
Senior
Education
Bachelor’s degree (or higher) in Statistics, Biostatistics, Computer Science, or a related field
Experience
12+ Years
📌 Head of Statistical Programming Operations (India)
🏢 Clymb Clinical
📍 India