Principal Stat Programmer(ADaM &TLF)

Overview

Lead statistical programming work using SAS to produce ADaM datasets and TLF outputs for clinical trials, acting as lead programmer for programming personnel.

What you'll do

• Use SAS or other software to develop custom programming code to generate summary tables, data listings, graphs and derived datasets as specified in the statistical analysis plan and programming specifications.
• Ensure outputs meet quality standards and project requirements.
• Perform validation programming and work with other programmers, biostatisticians and project team members to resolve discrepancies or findings.
• Keep project team members informed of programming progress and issues requiring their attention.
• Follow applicable SOPs, WIs and relevant regulatory guidelines (e.g. ICH).
• Maintain well organized, complete and up-to-date project documentation, testing, and verification/quality control documents and programs ensuring inspection readiness.
• Manage scheduling and time constraints across multiple projects at a time, set goals based on priorities from management, and adapt to timeline or priority changes by reorganizing daily workload.
• Develop specifications for datasets and outputs of any complexity according to statistical or sponsor requirements.
• Anticipate and address potential programming issues and accurately define all variables to be accepted by peer review and sponsor/requestor with little rework.
• Conduct effective internal meetings, distribute relevant information in advance, ensure minutes are promptly and accurately distributed, and follow action items through to completion.
• Display willingness to work with others and assist with projects and initiatives as necessary to meet the needs of the business.
• Be accountable for on-time delivery across concurrent programming deliverables.
• Negotiate programming timelines and provide risk mitigation plans for projects or programs, as needed.
• Proactively inform management of the status of deliverables and significant project or program issues, including planned resolutions.
• Act as the lead statistical programmer, direct the programming activities of other programming personnel, and monitor progress on programming deliverables.
• Review project documentation such as Statistical Analysis Plan, mock shells, programming specifications, annotated CRFs, and SAS database design.
• Provide feedback to project team members that reflects forethought and reduces inefficiencies in programming activities.
• Participate in sponsor meetings, kickoff meetings, and bid defense meetings as statistical programming representative, as required by sponsor.
• Contribute to mentoring programming personnel through developing training courses, presenting training materials, reviewing work, and providing feedback or guiding new associates.
• Maintain a good working knowledge of clinical drug development, industry standards, and electronic submission requirements; serve as a technical expert resource for complex programming questions.
• Work cooperatively with biostatistics and statistical programming personnel to establish SOPs, guidelines, policies and/or procedures.
• Contribute technical expertise to the development of programming tools and macros for standardization and efficiency.
• When serving as a subject matter expert for CDISC and other industry and regulatory requirements, provide guidance and training to the Biostatistics group and other departments on the appropriate use of CDISC Standards.
• When serving as a subject matter expert, perform compliance reviews of CDISC deliverables including SDTM and ADaM specifications and datasets and regulatory required documents (e.g. DEFINE.XML).
• When serving as a subject matter expert, actively participate in industry standards organizations and provide regular updates to the Biometrics Department on upcoming changes to those standards.
• Transfer deliverables and perform other work-related duties as assigned.

What you'll need

• Undergraduate degree, preferably in a scientific or statistical discipline; in lieu of degree, an equivalent combination of education and demonstrated programming experience.
• 8+ years programming experience in Clinical SAS, as demonstrated by the ability to lead multiple complex and/or global projects with teams of statistical programmers.
• Strong experience in ADaM and TLF.
• Excellent written and verbal communication skills.
• Ability to read, write, speak and understand English.

Nice to have

• Experience in submissions to a regulatory agency.
• Experience of pooling studies.
• Experience in mentoring others in the clinical trial process and CDISC Standards.

Details

• Location: IND-Remote.
• Minimal travel may be required.