Clinical Data Programmer

This position is fully remote and open to candidates based in India.

Human Predictions is searching for a candidate to support R package programming and data programming for clinical and nonclinical studies. The ideal candidate will also have experience with noncompartmental analysis (NCA) of pharmacokinetic (PK) data and an understanding of statistics related to NCA such as for bioequivalence studies. Experience with CDISC SDTM dataset use and creation along with generating tables, listings, and figures for clinical study reports is a strong plus.

The Clinical Data Programmer will primarily be responsible for designing, developing, validating, and documenting R code in open-source and internal packages. The work will include validating data edit checks, following or similar to CDISC SDTM compliant data sets. Potential candidates should have strong attention to detail and produce high-quality outputs. Other responsibilities include:

  • Programming of clinical data management metric reports for clients’ clinical studies;
  • Participate in and provide ongoing support for the evaluation, implementation, testing, and/or validation of electronic systems and programs used for clinical data, including system upgrades, according to regulatory requirements;
  • Create, implement, and execute import and export programs to output/receive data according to CDISC SDTM; and
  • Support creation and maintenance of Human Predictions programming standards and conventions using knowledge of industry and regulatory best practices (maintain currency in those best practices and data standards).

Qualifications:

  • MS, BS/BA degree or equivalent experience in Computer Science, Life Science, Statistics or related field with preferred minimum of 4-6 years of experience in clinical programming with the R programming language;
  • Post graduation experience programming with R in clinical study context in one of the pharmacy branches (Pharmacology, Pharmaceutics, physical pharmacy, Pharmacoinformatics, etc.);
  • Understanding and application of Regulatory Guidelines for the use of computer systems in clinical studies;
  • Working knowledge of global standards related to clinical study data management and programming activities is a strong plus (CRF design [CDASH], data standards [CDISC; SDTM and ADaM], database design, coding and coding dictionaries, etc.);
  • Technical abilities and skills in the analysis, design, specification, and programming of computer systems using tools such as SQL is a plus;
  • Experience using version control systems (e.g., Git, GitHub);
  • Computer skills (MS Office, word processing, spreadsheets, graphics, PowerPoint); and
  • Competencies and skills in the following: organization and technical project management; communication in English – verbal and written; execution/results/process improvement with the ability to translate business needs into technical requirements; industry awareness; influencing and team leadership; and ability to effectively problem solve both independently and with others.

How to Appy:

Interested candidates should send resume or CV to talent@humanpredictions.com with subject “Clinical Data Programmer”