Senior/Principal Statistical Programmer, ADaM, TLF

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.

• 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 issues that arise.

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

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

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

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

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

• Proactively identifies and resolves potential programming challenges, demonstrating foresight, establishing a foundation for efficient programming, and accurately defining all variables to be accepted by peer review and sponsors with minimal rework.

• Prepares for internal meetings in advance, shares ideas, and shows respect for the opinions of others.

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

• Distributes pertinent information ahead of time.

• Ensures that minutes are distributed promptly and accurately.

• Follows through on action items until completion, maintaining order and focus during meetings, while striving for consensus.

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

• Negotiates and establishes precise time estimates for completing study programming activities with internal team members and statistical programming management, delivering project programming activities within the designated timeframe.

• Serves as the lead statistical programmer.

• Oversees the programming activities of other programming personnel and tracks progress on 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 demonstrates foresight and minimizes inefficiencies in programming activities.

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

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

• Transfers deliverables.

• Completes other work-related duties as assigned.

• Occasional travel may be required.

⛳️ Requirements

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

• Requires 5+ years of experience in Clinical SAS programming.

• Must possess experience in Safety & Efficacy ADaM & TLF.

• Strong experience with Advanced SAS/SAS Macros is essential.

• Extensive programming experience in SAS or other required software, preferably within a clinical trial setting.

• Excellent written and verbal communication skills are mandatory.

• Experience in leading studies is required.

🏝️ Benefits

• We are dedicated to developing our people through career advancement opportunities;

• 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 genuinely be yourself.