Senior Statistical Programmer, ADaM, TLF, SDTM

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

📋 Description

• Utilizes SAS or other 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 all outputs align with quality standards and project specifications.

• 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 issues that require their attention.

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

• Maintains organized, complete, and up-to-date project documentation, testing, and verification/quality control documents and programs to ensure readiness for inspection.

• Manages scheduling and time constraints across multiple projects simultaneously, sets goals based on management priorities, and adjusts timelines or priorities by reorganizing daily workload.

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

• Proactively identifies and addresses potential programming challenges, demonstrating foresight and establishing a foundation for efficient programming while accurately defining all variables for peer review and sponsor/requestor acceptance with minimal rework.

• Prepares thoroughly for internal meetings, contributes ideas, and shows respect for others' opinions.

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

• Distributes relevant information beforehand.

• Ensures that minutes are distributed promptly and accurately.

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

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

• Negotiates and establishes accurate time estimates for the completion of study programming activities with internal team members and statistical programming management, completing project programming activities within the allotted timeframe.

• Serves as the lead statistical programmer.

• Directs the programming activities of other programming personnel and monitors 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 appropriate project team members that reflects foresight and minimizes inefficiencies in programming activities.

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

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

• Transfers deliverables.

• Performs additional work-related duties as assigned.

• Minimal travel may be necessary.

⛳️ Requirements

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

• Requires strong expertise in Base SAS/SAS Macros, ADAM & TLF programming, and specifications creation.

• Must possess a solid understanding of SDTM.

• Must have hands-on experience with both Safety & Efficacy outputs.

• Must have experience in Oncology therapeutic areas.

• Must have ISS/ISE experience and proficiency in 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 people through career development and progression.

• Supportive and engaged line management.

• Technical and therapeutic area training provided.

• Peer recognition and total rewards program.

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

• Driven to Deliver – capturing the passion of our colleagues to show up each day and create solutions that have the potential to significantly impact someone's life.

• We are continuously building the company we all aspire to work for and that our customers want to partner with.