Job Summary

This position is responsible for providing statistical guidance in development of clinical research programs and of individual studies as part of multi-disciplinary team. This role involves the development of Statistical Analysis Plans, encompassing statistical methodology, the definition of derived variables, formulation of data-handling rules, creation of mockups, and, ultimately, the analysis of study data to meet business needs.

Essential Duties & Responsibilities:

• 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 protocolsDevelop 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 TLFs 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 statisticiansExperienced with electronic data capture (EDC) system(s).Experience with electronic health records (EHR) system(s).

Competency Expectations:

• Experience supporting publication of analysis results (e.g. abstracts, posters, manuscripts) a plus.Excellent in both oral and written communications. 

• Advanced knowledge of clinical trial design and analysis.Must possess the ability to work and make guided independent decisions, understand basic medical information.

• Ability to explain statistical concepts to non-statisticians.Good organizational and time management skills.

• To be successful in this position it is important to have strong knowledge of regulatory guidelines (FDA/CFR; ISO14155).Motivated, self-starter with the ability to work with minimal supervision, Technical aptitude, attentiveness to detail, ability/willingness to work collaboratively as part of a team, and excellent communication skills.SAS proficiency including use of a variety of statistical procedures, e.g., nonparametric analysis, linear and non-linear models, categorical data and survival analysis.

Education/Special Training Required:

MS or PhD in statistics, mathematics, or related field.

Qualifications/Work Experience Required:

• Master’s level degree or equivalent in statistics, biostatistics or related field with medical research content.

• Minimum of 5-8 years of relevant experience inclusive of postgraduate years

• Strong/in-depth understanding of statistical theories and principles

• SAS programming and analysis of clinical trial data within medical device, pharmaceutical and/or biotechnology preferred.