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Job details:
Job Type: Full Time, Hybrid, Remote
Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences
Skills: ICH guidelines, ICSR Case Processing, Labelling Assessment, MedDRA Coding, mRS and EQ-5D-5L, Triage of ICSRs, WHO DD Coding
Biostatistical Programming Manager – Amgen
Location
Job Type
Department
- Clinical – Global Statistical Programming (GSP)
Experience Required
- 6+ years of statistical programming experience in a clinical development environment.
- Experience leading statistical programming activities for clinical trials, regulatory submissions, and global development programs is required.
- Prior experience managing or mentoring statistical programmers is preferred.
Estimated Salary Package (Market Standard)
- ₹35 – ₹60 LPA (approx.), depending on statistical programming expertise, leadership experience, therapeutic area knowledge, and interview performance.
Job Overview
The Biostatistical Programming Manager serves as a Study Lead Programmer (SLP), responsible for leading statistical programming activities across clinical studies and ensuring high-quality, compliant, and timely delivery of clinical trial outputs. The role combines technical leadership, programming strategy development, team management, regulatory submission support, and collaboration with global clinical teams.
Key Responsibilities
Study Lead Programming
- Lead end-to-end statistical programming activities for one or more clinical studies.
- Develop programming strategies and ensure delivery timelines, quality standards, and compliance requirements are achieved.
- Define programming scope and collaborate with statisticians and clinical study teams.
- Establish and maintain detailed programming timelines.
- Represent Global Statistical Programming (GSP) in Clinical Study Team (CST) meetings.
Statistical Programming & Data Standards
- Develop and maintain programming specifications including:
- SDTM (Study Data Tabulation Model)
- ADaM (Analysis Data Model)
- Define standards
- Perform hands-on statistical programming for complex clinical deliverables.
- Support integrated analyses involving multiple studies for regulatory submissions.
- Review database specifications, CRF development, IVRS specifications, and data quality checks.
- Ensure compliance with CDISC standards and clinical data requirements.
Team Leadership & Management
- Lead and mentor statistical programmers.
- Allocate programming tasks and monitor project progress.
- Provide technical guidance and support to programming teams.
- Conduct training and knowledge-sharing sessions.
- Ensure timely completion of high-quality programming deliverables.
Clinical Data & Regulatory Support
- Support regulatory submission activities for drug approvals.
- Coordinate data issue identification, tracking, and resolution.
- Manage technical programming environments and project requirements.
- Support automation, process improvement, and digital transformation initiatives.
Cross-Functional Collaboration
- Collaborate with:
- Biostatisticians
- Clinical Data Management teams
- Clinical Operations teams
- Regulatory teams
- Global programming stakeholders
- Drive effective communication across global and multicultural teams.
Educational Qualification
- Bachelor's or Master's degree in:
- Biostatistics
- Statistics
- Mathematics
- Computer Science
- Data Science
- Other quantitative or scientific disciplines
Preferred:
- Master's degree or higher in Statistics, Biostatistics, Mathematics, or related fields.
Required Skills
- Strong experience in clinical statistical programming.
- Advanced SAS programming skills, including SAS/STAT.
- Strong knowledge of:
- CDISC SDTM standards
- ADaM standards
- Define.xml standards
- Understanding of clinical trial processes from data collection to reporting.
- Experience preparing clinical trial datasets and statistical outputs.
- Knowledge of data quality and compliance checking tools.
- Strong project management and leadership abilities.
- Excellent problem-solving skills.
- Ability to manage multiple projects and priorities.
- Strong written and verbal English communication skills.
- Ability to work effectively with global teams.
Preferred Qualifications
- Experience supporting regulatory submissions for drug approvals.
- Knowledge of open-source programming tools:
- Experience with automation platforms and emerging technologies in statistical programming.
- Experience leading global clinical programming teams.
- Familiarity with digital transformation initiatives in clinical development.
Work Environment
- On-site role based in Hyderabad.
- Collaboration with global Clinical Development and Statistical Programming teams.
- Opportunity to work on innovative biotechnology and clinical research programs.
Who Should Apply
- Senior Statistical Programmers, Lead SAS Programmers, Statistical Programming Leads, and Clinical Data Programming Managers with 6+ years of experience.
- Professionals with strong SAS, CDISC, SDTM/ADaM expertise who want to move into strategic leadership roles in Clinical Trial Programming, Regulatory Submissions, and Global Biostatistical Operations.
Biostatistical Programming Manager – Amgen
Location
Job Type
Department
- Clinical – Global Statistical Programming (GSP)
Experience Required
- 6+ years of statistical programming experience in a clinical development environment.
- Experience leading statistical programming activities for clinical trials, regulatory submissions, and global development programs is required.
- Prior experience managing or mentoring statistical programmers is preferred.
Estimated Salary Package (Market Standard)
- ₹35 – ₹60 LPA (approx.), depending on statistical programming expertise, leadership experience, therapeutic area knowledge, and interview performance.
Key Responsibilities
Study Lead Programming
- Lead end-to-end statistical programming activities for one or more clinical studies.
- Develop programming strategies and ensure delivery timelines, quality standards, and compliance requirements are achieved.
- Define programming scope and collaborate with statisticians and clinical study teams.
- Establish and maintain detailed programming timelines.
- Represent Global Statistical Programming (GSP) in Clinical Study Team (CST) meetings.
Statistical Programming & Data Standards
- Develop and maintain programming specifications including:
- SDTM (Study Data Tabulation Model)
- ADaM (Analysis Data Model)
- Define standards
- Perform hands-on statistical programming for complex clinical deliverables.
- Support integrated analyses involving multiple studies for regulatory submissions.
- Review database specifications, CRF development, IVRS specifications, and data quality checks.
- Ensure compliance with CDISC standards and clinical data requirements.
Team Leadership & Management
- Lead and mentor statistical programmers.
- Allocate programming tasks and monitor project progress.
- Provide technical guidance and support to programming teams.
- Conduct training and knowledge-sharing sessions.
- Ensure timely completion of high-quality programming deliverables.
Clinical Data & Regulatory Support
- Support regulatory submission activities for drug approvals.
- Coordinate data issue identification, tracking, and resolution.
- Manage technical programming environments and project requirements.
- Support automation, process improvement, and digital transformation initiatives.
Cross-Functional Collaboration
- Collaborate with:
- Biostatisticians
- Clinical Data Management teams
- Clinical Operations teams
- Regulatory teams
- Global programming stakeholders
- Drive effective communication across global and multicultural teams.
Educational Qualification
- Bachelor's or Master's degree in:
- Biostatistics
- Statistics
- Mathematics
- Computer Science
- Data Science
- Other quantitative or scientific disciplines
Preferred:
- Master's degree or higher in Statistics, Biostatistics, Mathematics, or related fields.
Required Skills
- Strong experience in clinical statistical programming.
- Advanced SAS programming skills, including SAS/STAT.
- Strong knowledge of:
- CDISC SDTM standards
- ADaM standards
- Define.xml standards
- Understanding of clinical trial processes from data collection to reporting.
- Experience preparing clinical trial datasets and statistical outputs.
- Knowledge of data quality and compliance checking tools.
- Strong project management and leadership abilities.
- Excellent problem-solving skills.
- Ability to manage multiple projects and priorities.
- Strong written and verbal English communication skills.
- Ability to work effectively with global teams.
Preferred Qualifications
- Experience supporting regulatory submissions for drug approvals.
- Knowledge of open-source programming tools:
- Experience with automation platforms and emerging technologies in statistical programming.
- Experience leading global clinical programming teams.
- Familiarity with digital transformation initiatives in clinical development.
Work Environment
- On-site role based in Hyderabad.
- Collaboration with global Clinical Development and Statistical Programming teams.
- Opportunity to work on innovative biotechnology and clinical research programs.
Who Should Apply
- Senior Statistical Programmers, Lead SAS Programmers, Statistical Programming Leads, and Clinical Data Programming Managers with 6+ years of experience.
- Professionals with strong SAS, CDISC, SDTM/ADaM expertise who want to move into strategic leadership roles in Clinical Trial Programming, Regulatory Submissions, and Global Biostatistical Operations.
Click on Apply to know more.
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