Statistical Programmer, ADaM, TLF, SDTM

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

📋 Description

• Utilizes SAS or other software to create custom programming code that produces 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 fulfill project requirements.

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

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

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

• Maintains well-organized, comprehensive, and current project documentation, testing, and 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 timeline or priority changes by reorganizing the daily workload.

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

• Identifies and resolves potential programming issues proactively, 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) and distributes relevant information beforehand.

• Ensures that minutes are distributed promptly and accurately.

• Tracks action items to completion while maintaining order and focus during meetings, working toward consensus.

• Shows 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 deliverables.

• Negotiates programming timelines and develops 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.

• Oversees the programming activities of other programming personnel and monitors their progress on 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, reflecting foresight and minimizing 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 through processes.

• Maintains a strong understanding of clinical drug development, industry standards, and electronic submission requirements; serves as a technical expert resource for other department members on complex programming queries.

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

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

• Acts as a technical subject matter expert for CDISC and other industry and regulatory requirements, providing guidance and training to the Biostatistics group and other departments on the proper application of CDISC Standards.

• Conducts compliance reviews of project deliverables for CDISC, including SDTM and ADaM specifications and datasets, as well as any regulatory-required documents (e.g., DEFINE.XML).

• Actively engages in industry standards organizations and provides regular updates to the Biometrics Department regarding upcoming changes to those standards.

⛳️ Requirements

• Requires 8+ years of experience in Clinical SAS Programming.

• Requires strong proficiency in Base SAS/SAS Macros, SDTM, ADaM, and TLF programming as well as specification creation.

• Must have hands-on experience with both Safety and Efficacy data.

• Preferably has experience in Oncology therapeutic areas.

• Must possess ISS/ISE experience and knowledge of R programming.

• Excellent written and verbal communication skills are essential.

• Ability to read, write, speak, and understand English is required.

• Immediate joiners are preferred.

🏝️ Benefits

• We are dedicated to developing our employees through career advancement and progression.

• Supportive and engaged line management is provided.

• Offers technical and therapeutic area training.

• Includes a peer recognition and total rewards program.

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