Company Description

Ephicacy, founded in 2005 in New Jersey, US, specializes in data analytics services supporting research and clinical trials in the life sciences industry. With a strong presence in Bangalore, India, Ephicacy operates as a Centre of Excellence (CoE) delivering technology services in healthcare analytics. The company is ISO 9001:2015 and ISO 27001:2013 certified, with a dedicated team of biostatisticians, clinical SAS programmers, and data managers focused on clinical analytics.

Role Description

This is a full-time remote role for a Senior Technical Lead - Statistical Programming at Ephicacy. The role involves day-to-day tasks such as statistical programming, programming, data management, and utilizing macros. The Senior Technical Lead will be responsible for leading and overseeing statistical programming activities to support research and clinical trial data analysis.

Roles and responsibilities:

1) Primarily responsible for quality and timely delivery of SDTM and ADaM artifacts (Specifications, datasets, cSDRG, ADRG) and TFLs

2) Read and understand Clinical study protocol, Statistical Analysis Plan, Case Report Form (CRF), specifications and other study related documents.

3) Develop SAS programs to produce Analysis datasets, statistical tables, graphical representations, and data listings for individual study reports in accordance with the Statistical Analysis Plan (SAP)

4) Develop validation programs to validate outputs produced by other team members and perform validation on program code of other team members.

5) Provide support to Data Management in developing Edit check programs, listings or ad hoc reports as required

6) Develop Debug Utility macros for reusability and efficiency 

Skill Set -

1)Experience working on ADAM and TFL deliverables on multiple therapeutic areas and phases in clinical trials.

2) Experience creating and working with Utility Macros

3) Experience creating specifications

4) Experience with CDSIC standards including CDASH or SDTM/ADaM

5) Ability to work independently and as part of a team

6) Being open to new learnings and sharing with team members

7) Excellent communication skills [Written, Verbal, Interpersonal and organizational skills]

8) Proficient in using SAS EG/Studio for programming

9) Familiar with Unix environment and programming

10) Prior working experience in Oncology Therapeutic area is an added advantage

11) Familiarity with multiple statistical procedures and functions to create TFLs