Senior Statistical Programmer, ADaM, TLF

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

📋 Description

• Utilizes SAS or other software to craft custom 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 adhere to quality standards and meet 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 highlights issues that require their attention.

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

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

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

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

• Proactively identifies and addresses potential programming challenges, demonstrates foresight, establishes a foundation for efficient programming, and accurately defines all variables for peer review and sponsor approval with minimal rework.

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

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

• Distributes relevant information ahead of time.

• Ensures that meeting minutes are promptly and accurately communicated.

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

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

• Negotiates and establishes accurate time estimates for completing study programming tasks with internal team members and statistical programming management, ensuring project programming activities are completed within the designated timeframe.

• Serves as the lead statistical programmer.

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

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

• Provides constructive feedback to relevant project team members that reflects foresight and mitigates inefficiencies in programming tasks.

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

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

• Transfers deliverables as needed.

• Performs other work-related duties as assigned.

• Minimal 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 SAS Programming or other necessary software, ideally within a clinical trial context.

• Must possess strong expertise in CDISC- ADAM and TLF generation.

• Experience with submission activities is advantageous.

• Must have robust experience in Base SAS, Advanced SAS, and SAS Macros.

• Excellent written and verbal communication skills are essential.

• Proficiency in reading, writing, speaking, and understanding English is required.

🏝️ Benefits

• We are dedicated to nurturing our employees through career development and progression;

• supportive and engaged line management;

• technical and therapeutic area training;

• peer recognition and total rewards program.

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