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Staff Biostatistician in Fremont, CA at Stryker Corporation

Date Posted: 1/4/2019

Job Snapshot

Job Description

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 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.

  • Five years of postgraduate Experience in the application of statistics to clinical trials for employees with a PhD in a statistics subject; 8 years of postgraduate Experience in the application of statistics to clinical trials for employees with an MA/MS in a statistics subject
  • At least 5 years of experience with SAS programming.
  • 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
  • Experienced with electronic data capture (EDC) 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.

Work From Home: No

Travel Percentage: None

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.

Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.

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