Data Analyst cum Statistical Programmer
4 days ago
Job Description:
We are seeking a skilled Data Analyst cum Statistical Programmer to join our team at Biocon Biologics. The successful candidate will work closely with our cross-functional team of experts to perform biostatistical and SAS programming activities for clinical trials involving Novel, Biosimilar, and PMS studies.
Key Responsibilities:
- Provide SAS programming support to all clinical projects (Phase 1 to 4).
- Manage programming CROs providing oversight for programming deliverables.
- Create programming-related SOPs as necessary.
- Work in tandem with CRO's Biostatistics and SAS Programming and Data Management teams on various clinical projects.
- Provide statistical input into and review of statistical deliverables (i.e., analysis plans, table shells, programming and table specifications, data review, tables, listings, figures, and statistical sections for integrated reports).
- Perform data manipulation, analysis, and reporting of clinical trial data, both safety and efficacy, utilizing SAS programming.
- Apply SAS programming skills to create and validate datasets/analysis files, tables, listings, and figures (TLFs).
- Generate complex ad-hoc reports for publications.
- Reviews/Develops SAS macros, templates, and utilities for data cleaning and reporting.
- Reviews/analytics specified in the protocol or the Statistical Analysis Plan (SAP) is implemented while working with the biostatisticians.
- Reviews CRF annotations and data specifications & discuss data structures and participate in data review activities.
- Provide input into statistical programming solutions and/or ensure their efficient implementation.
- In consultation with the Biostatistician, responsible for reviewing of programming specifications of analysis datasets and pooled datasets.
- Maintain up-to-date knowledge of programming software (e.g., SAS) as well as industry requirements (e.g., CDISC SDTM/ADaM, eCTD, Define.xml), attend functional meetings, and trainings.
- Establish successful working relationships on individual studies with external associates according to agreed contract and internal business guidance.
- Performs quality control on final reports.
- Ensures the accuracy of statistical programming components of scientific reports and/or publications with high quality.
- Contributes to assigned parts of process improvement, standardization, and other non-clinical initiatives.
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