Senior Statistical Programmer

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

📋 Description

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

• Strives to ensure that outputs align with quality standards and project specifications.

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

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

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

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

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

• Develops specifications for datasets and outputs of varying complexity in accordance with statistical or sponsor requirements.

• Anticipates and resolves potential programming challenges, demonstrating foresight, establishing a foundation for efficient programming, and accurately defining all variables to facilitate peer review and sponsor/requestor approval with minimal rework.

• Conducts effective internal meetings, ensuring appropriate format, frequency, and attendance.

• Distributes relevant information ahead of time and ensures that meeting minutes are promptly and accurately shared.

• Follows through on action items to completion, maintaining order and focus during meetings and working towards consensus.

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

• Responsible for timely delivery of concurrent programming outputs.

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

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

• Serves as the lead statistical programmer.

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

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

• Provides feedback to the relevant project team members that reflects foresight and minimizes inefficiencies in programming processes.

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

• Contributes to the training of programming personnel by developing training courses, delivering training materials, reviewing work, and guiding new associates through processes.

• Maintains a solid understanding of clinical drug development, industry standards, and electronic submission requirements; acts as a technical expert resource for colleagues regarding complex programming inquiries.

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

• Contributes technical knowledge to the development of programming tools and macros aimed at standardization and efficiency.

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

• In the role of subject matter expert for CDISC and other industry and regulatory requirements, conducts compliance reviews of project deliverables for CDISC outputs including SDTM and ADaM specifications and datasets, as well as any documents required by regulations (e.g., DEFINE.XML).

• Actively engages in industry standards organizations and regularly updates the Biometrics Department on forthcoming changes to those standards.

• Transfers deliverables.

• Performs additional work-related tasks as assigned.

⛳️ Requirements

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

• Minimum of 8 years of Clinical SAS Programming experience.

• Strong expertise in ADaM & TLF programming, including safety & efficacy outputs.

• Experience in creating submission packages, including ADRG and define.xml.

• Familiarity with SDTM.

• Excellent written and verbal communication skills.

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

🏝️ Benefits

• We are committed to the development of our employees through career growth and advancement;

• Supportive and engaged line management;

• Technical and therapeutic area training;

• Peer recognition and a total rewards program.

• We are dedicated to fostering an inclusive culture where you can genuinely be yourself.