Role details

Contract type

Permanent contract

Employment type

Full-time (> 32 hours)

Experience level

Experienced

Experience required

2 years minimum

Compensation

$75,000.0 - $155,000.0

Working hours

Regular working hours

Job source

www.indeed.com

Tech stack

Computer Programming Data Visualization R (Programming Language) Graphical User Interface SAS (Software) Data Processing Macros Software Application Programming Information Technology

Job description

• Effectively design and code for assigned clinical project(s).Produce and deliver CDISC and regulatory compliant SDTM, and ADaM standard datasets.
• 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 SAS or R 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, as appropriate.
• 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.

Requirements

• MS in Statistics, Math, Computer Science with at least 2 year of programming experience using SAS or R in the pharmaceutical or biotech or CRO industry.
• Experience in providing statistical programming support to early and late phase clinical trials
• Excellent skills in SAS or R 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.

Benefits & conditions

• Dental insurance
• Health insurance
• Vision insurance

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