Senior Statistical Programmer Analyst
The Senior Statistical Programmer Analyst has responsibility for statistical programming support for the Pharma Development organization. He/she provides end to end statistical programming support in planning, specifying, designing, developing and implementing statistical software solutions for the reporting and analysis of clinical trials in accordance with applicable processes.
- Capable of leading statistical programming activities at study level or part of clinical project and prepares summarized information for clinical study team members.
- Assesses and clarifies requirements, develops programming specifications and statistical programming solutions to meet the project requirements.
- Accepts responsibility for accuracy and reliability of results and builds & monitors quality in every aspect of job activities in a risk based quality control environment.
- Provides proactively and independently technical solutions to a wide range of problems.
- Builds and maintains effective working relationships within cross-functional teams.
- Considers strategies that will enable a smooth transition of a study or other task and negotiates alternative timelines and scope based on resourcing/priority constraints.
- Adapts to changing circumstances, policies, work assignments & team members and explores new ways of working based on changing of these business needs.
Qualifications and Experience:
- BA, BS or advanced degree in mathematics, statistics, biological sciences, computer science or equivalent experience.
- At least 6 years SAS programming experience in clinical research preferably with emphasis in the development and support of the analysis of clinical trial
- In depth expertise of SAS programming (BASE SAS & statistical procedures, SAS macros, advanced data step). Optional: Experience of R programming and of proactive data visualization to support experts in other fields in their decision making.
- In depth experience in reporting clinical studies and pooling clinical data.
- Knowledge of statistical concepts (p-values, rates and proportion, frequencies, confidence intervals, survival analysis, non-parametric analysis). Capable of implementing these ideas in clear, efficient SAS or R programs.
- Expertise in relevant operating systems (Windows/UNIX) and in depth knowledge of Pharma industry data standards, such as CDISC/SDTM & ADaM and FDA/ICH guidelines.
- Proficient in problem solving. Able to efficiently debug and resolve issues in programming code produced by others.
- Understands major biostatistical deliverables (Analysis Plan, CSR) and the overall design of a clinical study and its statistical & clinical rationale.