Principal Programmer - Statistical Programming

SUMMARY:

The Principal Programmer/Associate Manager, Statistical Programming, Central Services will support statistical programming activities in areas such as integrated data and reporting, electronic submissions, exploratory analysis, and clinical trial data disclosure. The incumbent will participate in process and methodology development for department goals and SME topics.

JOB DUTIES:

Integrated Analysis support:

· Programming support in creating integrated datasets and reports

· Ensure timely and high-quality programming deliverables in assigned projects and areas.

· Create programming documentation, including Integrated dataset specifications (such as pooled ADaM) following programming standards and processes

Regulatory Submission oversight and support:

· Work with project programming teams and support the creation and review of electronic data packages for regulatory submissions, ensuring compliance with global regulatory standards (e.g., FDA, EMA, PMDA), industry standards (e.g., CDISC standards), and internal standards.

Clinical Transparency and Trial Disclosure (CTTD) support:

· Coordinate with Clinical Transparency and Trial Disclosure team, Statistical Programming, Biostatistician, and other functions to gather relevant details and deliver data sets and outputs required for disclosure

Technical Expertise and Leadership:

· Provide subject matter and technical expertise in developing tools and standard processes

· Troubleshoot and resolve programming and submission-related issues effectively.

· Support the implementation of best practices to enhance efficiency and compliance in assigned areas.

Inspection Readiness and Support:

· Support inspection preparation activities to ensure the team is fully prepared for regulatory agency inspections.

· Provide support during inspections, addressing any programming-related inquiries or findings.

Collaboration and Team Development:

· Collaborate with project programmers and cross-functional teams to meet submission and reporting objectives.

JOB REQUIREMENTS:

Technical Skills:

· Proficient SAS programming skills in a clinical data environment with expertise in at least one, preferably multiple, therapeutic areas. Knowledge of other programming languages such as R, Python etc. is highly desirable

· Proficient in the use of Pinnacle 21 (P21) tool and experience reviewing and troubleshooting P21 reports/issues

· Strong understanding of CDISC standards, including SDTM, ADaM, and Define-XML

· Familiarity with regulatory submission formats such as eCTD

Other Skills:

· Excellent communication and interpersonal skills

· Ability to collaborate across functional areas

· Strong problem-solving skills and ability to handle complex technical issues

· Strong attention to detail and ability to manage multiple priorities in a fast-paced environment

Required Special Equipment and/ or programs

· SAS, (Base, Stat, Macro, graph)

· SAS certification a plus

· Open-Source programming (R/Python) knowledge is a plus

EDUCATIONAL REQUIREMENTS:

MS. (BS.) in Statistics, Computer Science, Mathematics, Engineering, Life Science, or related discipline with 5+ (6+) years of programming experience, preferably in processing clinical trial data in the biotechnology, pharmaceutical, or health-related industry, including project and people

management experience. Proven experience in regulatory submissions and compliance with global standards (e.g., CDISC, FDA, EMA, PMDA).