R Statistical Programmer – Submission Experience Required

This is a fully remote position, open to applicants in Armenia, +3 more states.

📋 Description

• Utilizes R or other software to create customized programming code for generating summary tables, data listings, graphs, and derived datasets in accordance with the statistical analysis plan and programming specifications.

• Ensures that outputs adhere to quality standards and 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 requiring their attention.

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

• Maintains well-organized, complete, and up-to-date project documentation, testing, verification, quality control documents, and programs to ensure inspection readiness.

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

• Develops specifications for datasets and outputs of varying complexity based on statistical or sponsor requirements.

• Anticipates and addresses potential programming challenges, demonstrating foresight, establishing the foundation for efficient programming, and accurately defining all variables for peer review and sponsor acceptance with minimal rework.

• Conducts effective internal meetings (appropriate in format, frequency, and attendance).

• Distributes relevant information in advance, ensures minutes are promptly and accurately shared, follows through on action items to completion, and maintains order and focus in meetings, working towards consensus.

• Demonstrates a willingness to collaborate with others and assist with projects and initiatives as needed to meet business requirements.

• Responsible for timely delivery of concurrent programming deliverables.

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

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

• Acts as the lead statistical programmer, directing the programming activities of other programming personnel and overseeing progress on programming deliverables.

• Reviews project documentation such as Statistical Analysis Plans, mock shells, programming specifications, annotated CRFs, and SAS database design.

• Provides constructive feedback to relevant project team members to enhance efficiency in programming activities.

• Participates in sponsor meetings, kickoff meetings, and bid defense meetings as the statistical programming representative, as required by the sponsor.

• Aids in the mentoring of programming personnel by developing training courses, presenting training materials, reviewing work, and providing feedback or guidance to new associates in processes.

• Maintains a solid understanding of clinical drug development, industry standards, and electronic submission requirements; serves as a technical expert resource for complex programming inquiries within the department.

• Collaborates with other biostatistics and statistical programming personnel to establish standard operating procedures (SOPs), guidelines, policies, and/or procedures.

• Contributes technical expertise to the creation of programming tools and macros for improved standardization and efficiency.

• As a technical subject matter expert on CDISC and other industry and regulatory requirements, provides guidance and training to the Biostatistics group and other departments on appropriate CDISC Standards usage.

• As a subject matter expert on CDISC and other industry and regulatory requirements, conducts compliance reviews of project deliverables for CDISC standards, including SDTM and ADaM specifications and datasets as well as any regulatory-required documents (e.g., DEFINE.XML).

• As a subject matter expert on CDISC and other industry and regulatory requirements, actively engages with industry standards organizations and provides regular updates to the Biometrics Department on forthcoming changes to those standards.

• Performs other work-related duties as assigned.

⛳️ Requirements

• Bachelor’s degree, preferably in a scientific or statistical discipline; alternatively, an equivalent combination of education and demonstrated programming experience.

• Extensive programming experience in SAS or other required software, preferably in a clinical trial setting, showcasing the ability to lead multiple complex and/or global projects with teams of statistical programmers.

• Comprehensive knowledge and experience with CDISC Standards for regulatory agency requirements.

• Prior experience in submissions to a regulatory agency is preferred.

• Experience in mentoring others in the clinical trial process and CDISC Standards.

• Excellent written and verbal communication skills.

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

🏝️ Benefits

• We are dedicated to developing our team members through career advancement and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition; and a comprehensive rewards program.

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