Clinical Trials Data Analyst

We are seeking a Biostatistician and SAS Programmer to perform biostatistical and programming activities for clinical trials. This includes novel, biosimilar, and post-marketing studies. As a member of our team, you will work on various projects, collaborating with experts from different functional areas.

You will have the opportunity to develop your statistical skills and gain experience in multiple therapeutic areas. Your contributions will include research design and analytical strategies, input into protocols, and the development of statistical analysis plans.

As a Statistical Programmer, you will use your SAS programming skills to support Phase I-IV clinical trials. You will leverage your expertise in CDISC implementation (SDTMs, ADaMs) and TFLs, and experience in regulatory submissions as part of the Statistical Programming process. This will play a key role in supporting a growing pipeline across multiple therapeutic areas, with emphasis on regulatory submissions.

• 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.
• 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 your 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/anlayses 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, ), attend functional meetings and trainings.
• Establish successful working relationship 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

• Knowledge of applied parametric and non-parametric statistics, Mixed Model. Missing Data analysis, General Linear models - ANOVA, ANCOVA, t-test, etc Non-Parametric methods - Binomial test, Chi-Squared test, Wilcoxon tests; Logistic regression.
• Strong SAS/R programming skills in R software. Advanced SAS and other statistical computing software skills in a clinical data environment across multiple therapeutic areas.
• Good Knowledge of CDISC implementation (SDTMs, ADaMs)

• Master degree in statistics with Ideally 6+ years of work experience in a programming role preferably clinical trials/ or in pharmaceutical industry or CROs.
• Good SAS experience and proven skills in the use of SAS within a Statistical Programming environment to develop and validate deliverables.