SAS Programmer

K3 Innovations; United States; On-site; USD 150,000 - 210,000; Full time

Job summary

K3 Innovations is seeking an experienced Manager of Statistical Programming to lead programming efforts across multiple clinical studies. The role focuses on SAS programming expertise, CDISC standards, and strong leadership to ensure timely, compliant deliverables for clinical trials.

The successful candidate will oversee CROs, collaborate with Data Management and Biostatistics, and mentor a growing team while maintaining audit readiness and high-quality outputs for regulatory submissions.

Qualifications

• BS/MS degree in life science or related field and 5+ years in programming or statistics.
• At least 2+ years leading programs or coordinating large teams.
• Experience with regulatory guidelines (FDA, EMA, ICH).
• Proficient in SAS programming and CDISC standards.
• Ability to oversee CRO vendors and audits.

Responsibilities

• Lead statistical programming activities for multiple clinical trials.
• Ensure timely, high-quality programming deliverables.
• Audit readiness of statistical outputs.
• Produce tables, listings, figures, and datasets for regulatory and publication needs.
• Oversee CRO SAS programming and vendor progress.
• Collaborate with Data Management and Biostatistics to ensure database accuracy.
• Develop SDTM/ADaM specifications with biostatisticians.
• Create global tools to improve efficiency.
• Maintain up-to-date SAS knowledge and regulatory standards.
• Represent programming in audits and HA meetings.
• Provide technical recommendations at program level.
• Adhere to SOPs and guidelines.

Skills

Leadership experience

SAS programming

CDISC standards

GCP awareness

Regulatory knowledge

Vendor oversight

Audit readiness

Data analysis

Education

BS/MS degree in life science, computer science, statistics, mathematics, or equivalent relevant degree

Tools

SAS

SAS/GRAPH

BASE SAS

SAS Macro

Job description

Position Overview

We are seeking an experienced Manager of Statistical Programming to lead programming efforts across multiple clinical studies. This role will be instrumental in ensuring high-quality, timely, and compliant statistical deliverables in support of clinical trials. The ideal candidate will bring deep technical expertise in SAS programming and CDISC standards along with strong leadership and experience with vendor oversight.

Key Responsibilities

• Lead statistical programming activities for multiple clinical trials within a program
• Accountable for timely and quality development and validation of all statistical programming components on assigned program(s)
• Responsible for audit readiness of all assigned statistical programming deliverables as well as accuracy and reliability of statistical analysis results
• Serve as the lead programmer to produce and/or validate tables, listings, figures, and analysis datasets for regulatory requests, publication needs, and ad-hoc analyses; write specifications for programming requirements
• Oversee CRO SAS programming by providing ongoing review of activities and progress to ensure projects are delivered by the CROs on time with suitable quality
• Work closely with Data Management and Biostatistics teams to ensure the accuracy of final databases, analyses, and reports. Oversee study-level programming deliverable timelines in collaboration with the study lead biostatistician and cross-functional teams
• Collaborate with biostatisticians and clinical development colleagues to develop/review TFL shells, SDTM, and ADaM specifications
• Identify issues and develop global tools, such as macros or graphical user interface applications, to enhance the efficiency and capacity of the statistical programming group
• Maintain up-to-date advanced knowledge of SAS software as well as industry requirements (e.g. CDISC, eCTD, Define.xml), attend functional meetings and training
• Represent statistical programming at program-level, in audits/inspections and Health Authority (HA) meetings
• Offer expert technical and professional recommendations, thought leadership for the statistical programming function at the program level
• Adhere to FDA regulations regarding training records, guidelines, and SOPs. Adhere to company SOPs/WIs and department guidelines

Qualifications and Skills

• BS/MS degree in life science, computer science, statistics, mathematics, or equivalent relevant degree and 5+ years in a programming or statistical role
• At least 2+ years of experience as a Lead/Program/Project Programmer for one or more programs, including the coordination of large teams of internal and/or external programmers
• Demonstrated leadership, collaboration, and organizational skills with the ability to successfully manage and oversee multiple trials simultaneously, ensuring deadlines are met
• In-depth understanding of clinical trials methodology, regulatory requirements, and Good Clinical Practice (GCP)
• Advanced knowledge of industry standards, including CDISC standards, and a solid understanding of the development and use of standard programs
• SAS programming skills - procedures and options commonly used in clinical trials. reporting, including Macro language, BASE SAS, SAS/STAT, and SAS/GRAPH, validation/QC, experience generating listings, tables, figures
• Must be able to program defensively, check results, and consistently produce accurate outputs
• Knowledge of regulatory guidelines (FDA, EMA, ICH) relevant to clinical trials, statistics, and data handling, along with advanced knowledge of submission requirements and standards
• Experience in contributing to the review of statistical analysis plans and developing technical programming specifications
• Experience with outsourcing programming activities and overseeing services provided by CROs and contractors
• NDA submission experience a plus
• Excellent interpersonal skills with a proven ability to operate effectively in a global environment, influencing and communicating across functions and with external stakeholders
• The ability to thrive in various situations, enthusiastically embracing organizational changes and evolving job demands
• Skills planning and managing multiple responsibilities concurrently, while maintaining high standards of quality and meeting deadlines under pressure