Associate Director Statistical Programming

Acrosian LLC; India; On-site; INR 2,500,000 - 4,200,000; Full time

Job summary

Acrosian LLC seeks an Associate Director Statistical Programming to lead end-to-end programming for global clinical trials in a CRO setting. This senior role requires strategic oversight, stakeholder engagement, and driving process improvements while ensuring quality and regulatory readiness.

You will mentor programmers, manage resources, ensure CDISC standards compliance, and collaborate with Biostatistics, Data Management, Medical Writing, and external vendors to deliver submission-ready

Qualifications

• Master’s degree or higher in a relevant field.
• 12–15 years in pharma/CRO/biotech with 8–10 years in statistical programming and leadership.
• Strong SAS expertise; working knowledge of R and Python is advantageous.
• In-depth CDISC standards knowledge and regulatory submission experience.
• Experience in clinical trial programming from start-up through submission.
• Ability to interpret protocols and programming requirements to define strategies.
• Track record in multi-therapeutic delivery, sponsor governance, and risk management.
• Excellent communication, leadership, and client-facing skills.

Responsibilities

• Lead end-to-end statistical programming across global studies, ensuring quality and timeliness.
• Drive strategy, planning, execution, review, and completion of programming deliverables.
• Provide oversight for SDTM/ADaM datasets, CDISC standards, and TLFs.
• Review study documents to identify programming risks and data standards implications.
• Collaborate with Biostatistics to translate analysis requirements into specs and outputs.
• Manage resources, staffing, and delivery coverage across studies.
• Oversee QC/validation, documentation, and audit readiness of programming outputs.
• Engage with sponsors and CROs to ensure governance and issue resolution.
• Contribute to plans, standards, and automation initiatives within the function.

Skills

SAS

R

Python

CDISC standards

Leadership

Stakeholder management

Education

Master’s degree in Statistics/Biostatistics/Mathematics/Computer Science/Life Sciences

Tools

Pinnacle 21

Job description

Associate Director Statistical Programming

Location

Reports to

Senior Director, Director, or Head of Biometrics or Statistical Programming

The Associate Director Statistical Programming is a senior functional leader with an in-depth understanding of clinical trial statistical programming strategies, processes, technologies, and regulatory standards. This role is responsible for the end-to-end oversight and delivery of statistical programming services across global clinical trials and multi-therapeutic programs. Operating within a CRO service-based environment, the role ensures high-quality, compliant, and efficient programming services to sponsor companies while driving stakeholder engagement, governance, resource planning, and escalation management.
The Associate Director Statistical Programming collaborates closely with sponsors, Biostatistics, Data Management, Medical Writing, Clinical Operations, Quality Assurance, and external vendors to ensure programming deliverables are executed with accuracy, transparency, and scalability. This position contributes to the growth and development of Acrosian’s Biometrics function through technical leadership, people development, process improvement, and client partnership. Familiarity with emerging technologies, including artificial intelligence and machine learning, is expected to support automation, intelligent data review, and enhanced operational efficiency.
In addition, the Associate Director Statistical Programming plays a key role in change management and in advancing functional, technical, and scientific capabilities, processes, standards, and tools within the function.

• Lead and oversee end-to-end statistical programming activities across global clinical studies, ensuring quality, compliance, and timely delivery.
• Drive the strategy, planning, execution, review, and completion of programming deliverables within assigned scope, ensuring consistency, efficiency, and adherence to sponsor requirements.
• Provide technical and operational oversight for SDTM and ADaM datasets, annotated CRFs, define.xml, reviewers guides, and tables, listings, and figures (TLFs).
• Ensure compliance with CDISC standards, including SDTM, ADaM, CDASH, controlled terminology, and applicable regulatory guidance and submission expectations.
• Review protocols, statistical analysis plans, CRFs, data management plans, and related study documents to identify programming risks, data standards implications, and delivery requirements.
• Partner with Biostatistics to translate statistical analysis requirements into clear programming specifications, analysis datasets, and submission-ready outputs.
• Proactively evaluate and manage resource needs for assigned studies; coordinate with functional leadership and project management to ensure appropriate staffing, utilization, and delivery coverage.
• Anticipate, identify, prevent, and manage risks and issues that may impact study, sponsor, or departmental programming deliverables.
• Oversee programming quality-control and validation processes, including independent review, traceability, documentation, and audit readiness.
• Lead the programming contribution to study milestones, including interim analyses, data cuts, database lock, primary analysis, integrated summaries, and regulatory submissions.
• Collaborate with Data Management on external data transfers, reconciliation requirements, vendor data integration, data review, and database lock readiness.
• Create and review programming plans, specifications, validation plans, dataset and TLF metadata, submission documentation, and sponsor-specific programming standards.
• Engage with sponsors and CRO partners as a senior programming contact to ensure transparent communication, effective governance, and timely resolution of issues and escalations.
• Support proposal development, effort estimation, resourcing assumptions, bid defenses, scope discussions, and change-order assessments for CRO engagements.
• Develop, enhance, and maintain departmental SOPs, programming standards, reusable utilities, automation frameworks, and quality metrics.
• Mentor, coach, and guide statistical programmers and programming leads, fostering technical excellence, accountability, and knowledge sharing.
• Apply AI, machine learning, and automation concepts where appropriate to improve programming efficiency, data review, anomaly detection, and quality monitoring.
• Identify and communicate lessons learned, best practices, and opportunities for continuous improvement at the study and departmental levels.

Principal Relationships

• Functional contacts include Biostatistics, Data Management, Medical Writing, Clinical Operations, Clinical Database Programming, Project Management, Quality Assurance, Regulatory Affairs, and IT.
• External contacts include sponsors, CRO partners, technology vendors, and regulatory auditors.

Required

• Master’s degree in Statistics, Biostatistics, Mathematics, Computer Science, Life Sciences, or a related discipline; advanced degree preferred.
• 12–15 years of experience in the pharmaceutical, CRO, or biotechnology industry, with at least 8–10 years of progressive statisstical programming experience and demonstrated leadership responsibility.
• Strong hands-on expertise in SAS; working knowledge of R, Python, automation tools, or cloud-based analytics platforms is an advantage.
• In-depth knowledge of CDISC standards and regulatory submission requirements, including SDTM, ADaM, define.xml, reviewer’s guides, Pinnacle 21, and TLF delivery.
• Demonstrated experience in clinical trial programming from study start-up through database lock, analysis, reporting, and regulatory submission.
• Proven ability to interpret clinical trial protocols, statistical analysis plans, and clinical endpoints to define and drive programming strategies.
• Demonstrated success in multi-therapeutic-area delivery, sponsor management, governance, resource planning, and escalation handling.
• Experience working effectively with cross-functional stakeholders and geographically distributed teams.
• Excellent written and verbal communication, leadership, project management, and client-facing skills.

Preferred

• Experience supporting FDA, EMA, PMDA, or other global regulatory submissions.
• Experience in oncology, CNS, rare disease, immunology, cardiology, or early-phase clinical development programs.
• Prior CRO experience managing multi-sponsor portfolios and contributing to business development activities.
• Experience with real-world data, digital health technologies, data visualization, or external data integration.
• Track record of driving process improvement and automation initiatives using AI, machine learning, or advanced analytics technologies.

Other

• Domestic or international travel may be required for client meetings, industry conferences, and business needs.
• A strategic thinker with a hands-on leadership approach.
• A strong people leader with a track record of building and developing high-performing teams.
• Someone who can prioritize competing business needs, manage risk proactively, and drive execution in a fast-paced environment.
• A genuine customer focus and the ability to build trusted, long-term sponsor relationships.
• Passion for operational excellence, innovation, and continuous improvement.