Responsibilities:
- Design, develop, and deliver efficient, flexible, modular analysis, reporting, and submission standards for drug/vaccine projects across therapeutic areas.
- Adhere to departmental SOPs/guidelines; drive analysis/reporting data structures and standards; contribute to strategic initiatives.
Primary Activities:
- Develop and validate global programming standards for ADaM datasets.
- Develop and validate standards for efficacy and safety analysis/reporting.
- Design and develop complex programming algorithms.
- Provide technical consultation/support to statistical programmers and statisticians.
- Represent the company in industry initiatives (e.g., R Consortium, TransCelerate, PHUSE, CDISC).
- Collaborate with stakeholders to drive Analysis & Reporting standard programs.
Education and Minimum Requirement:
- BA/BS (CS, Statistics, Applied Mathematics, Life Sciences, Engineering or related) + 9+ years SAS clinical trial programming.
- MS in related field + 7+ years SAS clinical trial programming.
Required Skills/Experience:
- Interpersonal skills; strong written/oral/presentation skills.
- Experience delivering analysis/reporting (data, analyses, tables, listings, figures).
- Strong program-level project management and stakeholder engagement.
- Expertise in SAS clinical trial programming (data steps, procedures, SAS/MACRO, SAS/GRAPH) and familiarity with at least one other statistical software.
- Knowledge of CDISC SDTM and ADaM.
- Experience with analytical research databases; understanding of statistics/clinical trial/data management concepts.
Preferred Skills/Experience:
- Flexible/efficient complex SAS macro development; R/Python/XML; linked data/NLP; SAS/R in Unix/Linux; comprehend analysis plans and implement methods not in commercial tools; cross-cultural/geographic work; active in professional societies.
Application Instructions:
- Apply via https://jobs.merck.com/us/en (deadline stated on the posting).