Job Description
We are looking for multiple roles: Statistical Programmer using R, SAS for clinical studies and RWE:
Statistical Programmer using R for RWE
The Real-world Evidence & Advanced Analytics team within our sponsor’s Innovative Medicines is looking for outstanding R programmers whose responsibilities include:
Create analytic dataset by extracting, cleaning and harmonizing historical trial data and real-world data sources such as EHR, insurance claims, registry data.
Maintain clear and annotated documentation of entire code pipeline, including all data extraction, cleaning, and pre-analytic file variable creation
Proactively raise data issues and potential solutions, as well as reactively address issues raised by RWE researchers
Develop best practices for programming, and contribute to study protocols and statistical analysis plans
Identify common technical requirements for RWE projects, develop and maintain code repositories and tools that enable RWE researchers to accelerate project delivery.
Required qualifications:
A master’s degree in biostatistics, statistics, math or related field.
Expert coding skills using R or SQL
Extensive hands-on experience with data extraction, cleaning, and analysis
At least 5 years of relevant experience within biopharma companies, RWE consulting firms, or other relevant healthcare industries
Expertise with clinical trial data structure and real-world data sources (EHR, insurance claims, registry data)
Excellent interpersonal and communication skills
Statistical Programmer using R and SAS:
R is must have for the potential candidate. SAS is highly desirable skillset
· Create and validate tables, figures and listings (TFLs) working closely with cross-functional teams in a timely and high quality fashion, consistently meeting objectives of the study, and regulatory requirements.
· Perform quality control checks/validation of R or SAS code and output produced by other Statistical Programmers for SDTM datasets, ADaM datasets and TFLs.
· Create and review aCRF, SDTM and ADaM datasets specifications for datasets programming.
· Provide programming support for adhoc analysis and periodical safety reports.
· Identify problems and develop global tools that increase the efficiency and capacity of the Statistical Programming group (e.g., macros or graphical user interface applications).
· Provide oversight of statistical programming activities of vendors.
· Participate in development of Statistical Programming deliverables processes and standards using R/SAS.
· Developing applications and tools in support of data visualization, exploratory analysis and reporting, including the use of R Shiny as the reporting layer, and R and/or SAS for any pre-processing/data manipulation.
Qualifications
· MS in Statistics, Math, Computer Science with at least 2 year of R programming experience in the pharmaceutical or biotech or CRO industry.
· Experience in providing statistical programming support to early and late phase clinical trials
· Excellent skills in R and SAS programming and statistical reporting.
· In-depth knowledge of CDISC standards for SDTM and ADaM and FDA electronic data submission requirements.
· Familiarity with FDA and ICH regulations and guidelines.
· Excellent problem-solving skills.
· Excellent written and verbal communication skills and organizational and documentation skills.
· Demonstrate positive attitude and the ability to work well with others.
TechData is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.Company Description
Hybrid remote