What you will do
As the Senior Staff Biostatistician, you are responsible for providing statistical guidance in development of clinical research programs and of individual studies as part of multi-disciplinary team. This position is responsible for development of Statistical Analysis Plans, including statistical methodology, definition of derived variables, data-handling rules, mockups and ultimately analysis of study data in support of business needs.
- Provide timely and scientifically sound statistical expertise to clinical development projects.
- Participate in department and cross-functional meetings to optimize clinical study designs, endpoints, and analysis strategies.
- Collaborate with members of project teams to establish project timelines and to develop and implement protocols
- Develop statistical analysis plans, coordinate and perform data analysis and validation as necessary, and provide data interpretation.
- Provide statistical input to regulatory requests to support and defend clinical programs.
- Collaborate with clinical scientists, thought leaders, and medical writers, both internally and externally, in the publication of study data.
- Stay current with new developments in statistics, SAS programming, and regulatory guidance through literature review, conference attendance, etc.
- Perform inferential analyses; inputs to the statistical section of the clinical study report (CSR) and review clinical study report. Provide support for the study team to move CSR through the review and approval process. Provide statistical insight into interpretation and discussion of study results.
- Develop and test SAS programs to generate data sets, tables, listings, and graphs.
- Develop and test SAS programs to complete quality control and validation work on SAS programs, data sets and TLGs generated by others.
- Develop SAS programs to create derived variables and data sets (e.g., LOCF (Last Observation Carry Forward), adverse events with multiple merging and cleaning procedures), or perform other required advanced data manipulation to support completion of biostatistics projects; SAS, SQL & Macro skills required.
- Create documents to describe SAS programs as assigned such as specifications for protocol analysis data sets.
- Provide guidance to junior level programmers or statisticians.
What you need
- A minimum of a Master's Degree is required.
- A minimum of SAS proficiency including use of a variety of statistical procedures, e.g., nonparametric analysis, linear and non-linear models, categorical data and survival analysis required.
- A minimum of seven years of experience in the application of statistics, biostatistics, epidemiology or related field required.
- Programming experience in SAS or R required.
- Knowledge of clinical trial design and analysis required.
- Knowledge of regulatory guidelines (FDA/CFR; ISO14155) preferred.
- Experience supporting publication of analysis results (e.g. abstracts, posters, manuscripts) preferred.
- Experienced with electronic data capture (EDC) system(s) required.
- Excellent in both oral and written communications.
- Ability to explain statistical concepts to non-statisticians.
- Good organizational and time management skills.