Contractor​/Senior Statistical Programmers

Description

Serves as the study Statistician on clinical trial projects. Provides scientific and therapeutic area thought for study design and statistical analysis issues. Serves as scientific strategy consultant to clients for drug development planning. Maintains expertise in data manipulations and statistical analyses.

Required

Education and Experience:

• Ph.D. in statistics, biostatistics, applied mathematics, or mathematics.
• At least 4 years working experience.

• Strong theoretical background and applied statistical knowledge.
• Demonstrated research ability with published papers.
• Strong knowledge and skills of programming in SAS, S‑plus, and R.
• Excellent verbal and written communication skills.
• Positive attitude and the ability to work well with others in a multi-disciplinary setting.
• Must be able to multi‑task and pay close attention to detail.
• Good organizational skills with the ability to adapt and adjust to changing priorities.
• Ability to communicate complex statistical concepts in a multi‑disciplinary setting.

Act as a statistical programmer at client site for SDTM and ADaM and TLF programming aspects of clinical trials. Responsibilities include assessing requirements, reviewing and validating SDTM mapping specs and datasets, developing programming specifications for ADaM datasets for both efficacy and safety analyses, producing tables, listings, and figures, and communicating with other functions.

Must have MS in Biostatistics, Computer Science, Math, or related field and at least 3 years of SAS statistical programming experience within the Biotechnology and/or Pharmaceutical industry.

Knowledge of and experience in R and/or R Shiny is a plus.

North New Jersey and Boston area. One year contract, renewable.

Research, analyze and design statistical protocol for phase I‑III clinical trials applying principles of biostatistics and statistics;
Lead statistics study program design and programming activities for clinical trial and studies using statistical inference;
Review clinical trial statistical study design, protocols and statistical analysis plans using SAP;
Create and review statistical analysis tables, figures and listings for clinical trial reports;
Validate efficacy data‑sets;
Provide statistical analysis advice and guidance on drug development planning;
Analyze, summarize and interpret large clinical trial and bio‑statistics data by utilizing mathematical and statistical methodology;
Perform statistical analysis with linear statistical models, mixed model repeat measurement and longitudinal data analysis, survival and time‑to‑event analysis, bootstrap methods and multivariate analysis.

Must have a Ph.D. in Statistics or Biostatistics plus skills and knowledge in Survival Analysis, Linear Statistical Models, Analysis of longitudinal data, Statistical Inference, Bootstrap methods, Multivariate Analysis.