Work Flexibility: Hybrid
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. What you need: 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. What you need: 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 6-8 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. Travel Percentage: 10% Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. We are proud to be named one of the World’s Best Workplaces! For more information, visit: www.stryker.com Work Flexibility Remote – Role allows you to work the majority to 100% of time from an alternate workplace. These roles could have travel expectations, and you must work within the country of the job requisition location. Field-based – You can expect to regularly work a majority to 100% of time at customer facilities and has a set territory or expectation to travel within a set boundary. Almost all sales roles would likely be qualified as field-based. Onsite – Role is 100% located at a Stryker facility. Some ad hoc flexibility may be available depending on role, level, and job requirements. Manufacturing roles and any role that requires physical presence at the office would qualify under this category. Hybrid – You can expect to regularly work in both an alternate workplace and a Stryker facility. Roles that are partially remote or co-located would qualify as hybrid, and the expectation to be onsite would be defined and agreed upon by your manager/supervisor.