Data Analysis Specialist

1 week ago

ballari, India beBeeStatistical Full time

Job Title: Senior Statistical Programmer Clinical Programming Expert WantedDevelop and implement robust clinical trial datasets and outputs using industry-standard tools like SAS and R.Oversee the creation and review of SDTM and ADaM specifications to ensure seamless data integration and regulatory compliance.Design and execute comprehensive statistical programming deliverables, including TLF (Tables, Listings, Figures) programming, and preparation of Define.xml and reviewer's guides.Maintain and enhance macros to support study and project requirements, ensuring timely and high-quality deliverables.Work independently with minimal oversight, demonstrating a strong sense of ownership and accountability for assigned tasks.Communicate proactively with internal teams, providing clear updates and technical guidance to ensure cross-functional collaboration and success.Identify opportunities for process improvements and contribute suggestions to strengthen team efficiency and performance.Preferred Qualifications:Prior experience working in global or geographically distributed teams to ensure effective communication and collaboration.In-depth knowledge of CDISC standards and regulatory submission requirements to drive data integrity and compliance.Experience supporting FDA and PMDA submissions to meet regulatory needs and expectations.Ability to manage multiple studies simultaneously and prioritize tasks effectively to meet deadlines and deliverables.Strong documentation, planning, and organizational skills to maintain accuracy and productivity.Experience mentoring or providing technical oversight to junior programmers to foster growth and development.Key Responsibilities:Program, validate, and maintain clinical trial datasets and outputs.Lead and execute the full spectrum of statistical programming deliverables.Prepare and maintain macros to support study and project requirements.Communicate proactively with internal teams and stakeholders.Why This Role Matters:This role is crucial in ensuring the successful delivery of clinical trials and driving business growth. The ideal candidate will possess a unique blend of technical expertise, business acumen, and interpersonal skills to excel in this position.

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