Principal Statistical Programmer, SDTM, ADaM

This is a fully remote position, open to applicants in United Kingdom.

📋 Description

• Utilizes SAS or other software to create custom 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 comply with quality standards and fulfill project requirements.

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

• Keeps project team members apprised of programming progress and any issues that require their attention.

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

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

• Manages scheduling and time constraints across multiple projects simultaneously, establishes 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 according to statistical or sponsor requirements.

• Proactively identifies and resolves 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.

• Facilitates effective internal meetings (with appropriate format, frequency, and attendance).

• Distributes pertinent information in advance. Ensures minutes are timely and accurately shared. Follows through on action items to completion, maintaining order and focus during meetings while working towards consensus.

• Demonstrates a willingness to collaborate with others and support projects and initiatives as necessary to fulfill business needs.

• Holds accountability for timely delivery of concurrent programming deliverables.

• Negotiates programming timelines and formulates risk mitigation plans for projects or programs as required.

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

• Serves as the lead statistical programmer.

• Oversees the programming activities of other programming personnel and monitors the progress of programming deliverables.

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

• Provides constructive feedback to relevant project team members that reflects foresight and minimizes inefficiencies 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 offering guidance or support to new associates.

• Maintains a strong working knowledge of clinical drug development, industry standards, and electronic submission requirements; acts as a technical expert resource for other department members regarding complex programming inquiries.

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

• Contributes technical expertise towards the development of programming tools and macros for standardization and efficiency.

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

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

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

• Transfers deliverables.

• Performs other work-related duties as assigned.

⛳️ Requirements

• Bachelor’s degree, ideally in a scientific or statistical field; in the absence of a degree, an equivalent combination of education and demonstrated programming experience is acceptable.

• Significant programming experience in SAS or other requisite software, preferably in a clinical trial setting, as evidenced by the ability to lead multiple complex and/or global projects with teams of statistical programmers.

• Familiarity and experience with CDISC Standards for regulatory agency requirements.

• Preferred experience in submissions to regulatory agencies.

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

• Exceptional written and verbal communication skills.

• Capable of reading, writing, speaking, and understanding English.

🏝️ Benefits

• We are dedicated to the development of our people 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 be your authentic self.