Sr. Manager, Statistical Programming

Emmess Services; Bengaluru; On-site; INR 4,000,000 - 7,000,000; Full time

Job summary

Emmess Services in Bengaluru, India, seeks a Senior Manager, Statistical Programming to lead a team of statistical programmers and oversee planning, execution, and delivery of programming activities across clinical programs.

The role emphasizes SAS programming, CDISC standards, and regulatory submission experience, with leadership in managing complex projects and cross-functional collaboration.

Qualifications

• Bachelor's or Master's degree in Computer Science, Statistics, Mathematics, Life Sciences, or a related field.
• 10+ years in statistical programming in the pharmaceutical, biotech, or CRO industry.
• 1-3 years in a management or senior team lead role.

Responsibilities

• Leadership Team Management: Lead, mentor, and develop a team of statistical programmers, providing guidance on technical and project related matters.
• Allocate resources and assign projects across studies and programs to meet corporate and clinical timelines.
• Conduct performance reviews, support career development, and foster a culture of accountability and innovation.
• Project Technical Oversight: Oversee the development, validation, and documentation of SDTM, ADaM datasets, and TLFs for clinical trials and regulatory submissions.
• Act as lead programmer for high profile or complex studies, ensuring high quality deliverables.
• Review and approve programming specifications and outputs, ensuring consistency and accuracy.
• Strategic Cross Functional Collaboration: Collaborate with Biostatistics, Clinical Data Management, Regulatory Affairs, and external vendors to define data and analysis requirements.
• Serve as the primary programming point of contact for internal stakeholders and regulatory authorities, as needed.
• Participate in strategic planning and resource forecasting for clinical programs.
• Quality, Compliance Innovation: Ensure adherence to internal SOPs, ICH GCP guidelines, CDISC standards (SDTM/ADaM), and regulatory submission requirements (e.g., FDA, EMA).
• Support regulatory submission activities including preparation of define.xml, reviewers guides, and integrated summaries (ISS/ISE).
• Drive process improvement and contribute to the development of global programming standards and automation tools.
• Performs other duties as assigned.
• Complies with all policies and standards.

Skills

SAS (Base, Macro, SQL)

CDISC SDTM/ADaM

Education

Bachelor's or Master's degree in CS/Statistics/Life Sciences

Job description

Job Summary

The Senior Manager, Statistical Programming is a leadership role responsible for overseeing a team of statistical programmers and managing the planning, execution, and delivery of programming activities across clinical development programs. This individual ensures the quality, timeliness, and regulatory compliance of all statistical programming deliverables, and serves as a strategic partner to cross functional teams including Biostatistics, Data Management, and Clinical Operations. The role requires strong technical expertise in SAS programming, CDISC standards, and regulatory submission experience, as well as demonstrated leadership in managing teams and complex clinical projects.

Responsibilities

• Leadership Team Management: Lead, mentor, and develop a team of statistical programmers, providing guidance on technical and project related matters.
• Allocate resources and assign projects across studies and programs to meet corporate and clinical timelines.
• Conduct performance reviews, support career development, and foster a culture of accountability and innovation.
• Project Technical Oversight: Oversee the development, validation, and documentation of SDTM, ADaM datasets, and TLFs for clinical trials and regulatory submissions.
• Act as lead programmer for high profile or complex studies, ensuring high quality deliverables.
• Review and approve programming specifications and outputs, ensuring consistency and accuracy.
• Strategic Cross Functional Collaboration: Collaborate with Biostatistics, Clinical Data Management, Regulatory Affairs, and external vendors to define data and analysis requirements.
• Serve as the primary programming point of contact for internal stakeholders and regulatory authorities, as needed.
• Participate in strategic planning and resource forecasting for clinical programs.
• Quality, Compliance Innovation: Ensure adherence to internal SOPs, ICH GCP guidelines, CDISC standards (SDTM/ADaM), and regulatory submission requirements (e.g., FDA, EMA).
• Support regulatory submission activities including preparation of define.xml, reviewers guides, and integrated summaries (ISS/ISE).
• Drive process improvement and contribute to the development of global programming standards and automation tools.
• Performs other duties as assigned.
• Complies with all policies and standards.

Qualifications

• Bachelors Degree Computer Science, Statistics, Mathematics, Life Sciences, or a related field. Required or Masters Degree Computer Science, Statistics, Mathematics, Life Sciences, or a related field.
• Preferred 10+ years in statistical programming in the pharmaceutical, biotech, or CRO industry.
• Required 1-3 years in a management or senior team lead role.
• Required Expert proficiency in SAS (Base, Macro, SQL), and strong knowledge of CDISC (SDTM/ADaM).
• High Proven track record in supporting regulatory submissions (e.g., NDA, BLA, MAA).
• High Strong understanding of clinical development processes and regulatory requirements.
• High Excellent organizational, leadership, and communication skills.

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.