Statistical Programmer, ADaM, TLF, SDTM

📋 Description

• Utilizes SAS or other software to create custom programming code for generating summary tables, data listings, graphs, and derived datasets as outlined in the statistical analysis plan and programming specifications.

• Ensures that outputs adhere to quality standards and meet project requirements.

• Conducts validation programming and collaborates with other programmers, biostatisticians, and project team members to address discrepancies or findings.

• Keeps project team members updated on programming progress and issues that require their attention.

• Adheres to applicable SOPs, WIs, and regulatory guidelines (e.g., ICH).

• Maintains organized, complete, and current project documentation, testing, and verification/quality control documents and programs to ensure readiness for inspection.

• Manages scheduling and time constraints across multiple projects simultaneously, setting goals based on management priorities and adapting to changes in timeline or priorities by reorganizing daily workload.

• Develops specifications for datasets and outputs of varying complexity according to statistical or sponsor requirements.

• Anticipates and mitigates potential programming issues, demonstrating foresight, establishing a foundation for efficient programming, and accurately defining all variables for peer review and sponsor/requestor acceptance with minimal rework.

• Conducts effective internal meetings (appropriate in format, frequency, and attendance), distributes relevant information in advance, ensures prompt and accurate distribution of minutes, follows through on action items, and maintains order and focus in meetings while striving for consensus.

• Shows a willingness to collaborate with others and assist with projects and initiatives as necessary to meet business needs.

• Responsible for timely delivery across concurrent programming deliverables.

• Negotiates programming timelines and provides risk mitigation plans for projects or programs as necessary.

• Proactively updates management on the status of deliverables and significant project or program issues, including planned resolutions.

• Serves as the lead statistical programmer, directing the programming activities of other personnel and monitoring progress on programming deliverables. Reviews project documentation such as Statistical Analysis Plans, mock shells, programming specifications, annotated CRFs, and SAS database design, providing feedback to project team members that reflects foresight and minimizes inefficiencies in programming activities.

• Participates as the statistical programming representative in sponsor meetings, kickoff meetings, and bid defense meetings as required by the sponsor. Aids in mentoring programming personnel by developing training courses, presenting training materials, reviewing work, and guiding new associates in processes.

• Maintains a comprehensive understanding of clinical drug development, industry standards, and electronic submission requirements; acts as a technical expert resource for other department members concerning complex programming inquiries. Collaborates with other biostatistics and statistical programming personnel to establish standard operating procedures (SOPs), guidelines, policies, and/or procedures. Contributes technical expertise in developing programming tools and macros for standardization and efficiency.

• Acts as a subject matter expert for CDISC and other industry and regulatory requirements, offering guidance and training to the Biostatistics group and other departments on the appropriate application of CDISC Standards. Performs compliance reviews of project deliverables for CDISC outputs, including SDTM and ADaM specifications and datasets, as well as any regulatory-required documents (e.g., DEFINE.XML). Actively participates in industry standards organizations and provides regular updates to the Biometrics Department on upcoming changes to those standards. Transfers deliverables and performs other work-related duties as assigned.

⛳️ Requirements

• Minimum 8 years of experience in Clinical SAS Programming.

• Strong expertise in Base SAS/SAS Macros, SDTM, ADaM, and TLF programming, as well as specifications creation.

• Hands-on experience with both Safety and Efficacy outputs.

• Experience in Oncology therapeutic areas is required.

• Knowledge of ISS/ISE and proficiency in R programming.

• Excellent written and verbal communication skills.

• Proficient in reading, writing, speaking, and understanding English.

• Preference for immediate joiners.

🏝️ Benefits

• We are dedicated to developing our people through career development and progression, supportive and engaged line management, technical and therapeutic area training, peer recognition, and a total rewards program.

• We are committed to fostering an inclusive culture where you can authentically be yourself.