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
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