Senior Statistical Programmer

About VAICS

VAICS Consulting is a prominent leader in the data science and technology sector, delivering innovative solutions across diverse industries. Their expertise encompasses Biostatistics, Statistical Programming, Clinical Data Management, Medical Writing, and Clinical Monitoring and Operations within Life Sciences. The company supports the entire clinical trial lifecycle from data collection to regulatory submission, ensuring accuracy, compliance, and accelerated market approval.

Key Responsibilities

• Serve as the Trial Programmer for studies of moderate complexity, collaborating closely with project leads and client representatives to define project objectives and schedules.
• Lead as a contributing member within multi-disciplinary clinical trial teams, maintaining active and frequent communication throughout project phases.
• Design, implement, maintain, and validate programs that facilitate data transfer across various data management and operating systems, integrating datasets from multiple sources and formats.
• Generate and store summary data, produce listings, tables, and figures through SAS programming, ensuring thorough program validation.
• Manage assignments diligently to meet deadlines and uphold high-quality standards, respecting contractual requirements.
• Enhance professional knowledge in programming, technology, clinical trials, and pharmaceutical industry trends.
• Mentor junior team members by providing guidance and training.
• Support departmental infrastructure by representing VAICS at industry events, delivering presentations, contributing to training materials, and aiding in the formulation of departmental policies and SOPs.
• Create specifications and develop, validate, and deliver CDISC SDTM and regulatory documents, including eCRT Define.xml and SDTM aCRF.
• Analyze and consolidate data from diverse origins, including virtual trials and wearable technology data.
• Prepare statistical safety reports such as TLFs, safety event notifications, and data alerts for study teams.
• Offer consultation, analysis, and support across therapeutic areas to ensure CDISC compliance and consistent data mapping.
• Assume programming lead responsibilities on Phase II-IV clinical studies of simple to moderate complexity, including managing timelines, resources, and budgeting, and conducting team meetings as necessary.

Qualifications and Experience

• Bachelor's or Master's degree in Computer Science, Biostatistics, Statistics, Mathematics, or a related discipline.
• Minimum of 5 years' experience within the clinical research field, preferably with a CRO background.
• Proficient in SAS programming with comprehensive knowledge of SDTMs/ADaMs and TLFs development.
• Strong understanding of relational database structures and complex data systems.
• Experience in project management or team leadership roles is advantageous.
• Ability to provide mentorship and foster collaborative teamwork within multidisciplinary teams.
• Expertise in at least two therapeutic areas, including oncology.
• Experience with ISS/ISE/Submissions/RTQs and familiarity with agile methodologies.
• Fluency in English language is mandatory.

Eligibility

Candidates holding a B.Pharma degree in Clinical Pharmacy are eligible to apply.