Manager, Statistical Programming

Job Summary

We are looking for an experienced Statistical Programmer with strong hands-on expertise in SAS programming and deep knowledge of CDISC standards, including SDTM and ADaM. This role will be responsible for independently developing, validating, and maintaining SAS/R programs including development of analysis datasets and production of TFLs to support clinical studies and regulatory submission deliverables, with oversight and guidance responsibilities. It requires a deep understanding of clinical trial design and data analysis.

Key Responsibilities

• Develop and validate datasets in compliance with dataset specifications following CDISC standards (SDTM and ADaM) and study requirements.
• Program, generate, and quality check TFLs for efficacy and safety analyses for clinical study report or regulatory submissions following SAP, mock shells and internal standards.
• Perform SAS and R statistical programming.
• Contribute to the preparation and review of programming deliverables across multiple studies or projects.
• Collaborate closely with Biostatistics, Data Management, Clinical, and other cross-functional teams to resolve data issues and support study objectives.
• Support creation and maintenance of programming documentation, specifications, and standard processes.
• Contribute to process improvements, standardization efforts, and development of reusable programming tools such as macros and templates.
• Ensure timely delivery of high-quality programming outputs in a fast-paced clinical development environment.
• Provide technical guidance and day-to-day support to junior programmers or peers as needed.
• Participate in code review, debugging, and validation activities to support quality and consistency across programming deliverables.
• Validating/debugging the codes written by other team members.
• Maintain quality and timeliness of project work.

Qualifications

• Master's or Bachelor's degree in Data Science such as Statistics, computational biology, bioinformatics, computer science, or a related field
• High experience in CDISC-compliant statistical programming in SAS, with the aim of increasing efficiency.
• Strong understanding of CDISC standards, including SDTMIG and ADaMIG.
• Demonstrated experience in developing efficacy and safety TFLs.
• Good understanding of clinical trial processes, clinical data structures, and statistical reporting requirements.
• Ability to work independently while managing multiple priorities and deadlines.
• Strong problem-solving, organizational, and communication skills.
• Comfortable working across multiple phases of clinical development and able to shift gears quickly.
• Strong understanding of clinical trial design, data analysis, and regulatory requirements.
• Excellent problem-solving skills and attention to detail.

Preferred Qualifications

• Experience of working with international teams remotely is a plus.
• Statistical background or knowledge is a plus.
• Experience with submission-related deliverables such as Define.xml, SDRG, ADRG, P21 reports or related documentation is a plus.
• Experience with integrated summaries of safety (ISS) and efficacy (ISE) is a plus.

Experience

• Minimum of 7+ years of relevant experience in clinical statistics in industry (pharmaceuticals, biotechnology, or CRO).

Job Type

Full time

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