Role & responsibilities

- Minimum 1 year of hands-on R programming experience is mandatory.
- Experience in Safety or Efficacy analysis programming within clinical trials.
- Hands-on experience in the creation of efficacy datasets and efficacy outputs (Tables,

Listings, and Figures).

- Experience in ADaM specification writing for Safety and/or Efficacy studies.
- Experience in preparing Analysis Data Reviewers Guide (ADRG) and Define.xml.
- Experience using Pinnacle 21 (P21) for dataset validation and regulatory compliance

checks.

- Robust knowledge of CDISC SDTM and ADaM standards.
- Experience with SAS programming and clinical study submissions is preferred.

Essential Functions

- Perform, plan and co-ordinate the following for complex studies: (i) the programming,

testing, and documentation of statistical programs for use in creating statistical tables,

figures, and listing summaries and (ii) the programming of analysis databases (derived

datasets) and transfers of data for internal and external clients. May perform and plan

the programming of database quality control checks.

- Program and plan the integration of databases from multiple studies or sources.




- Develop and co-ordinate programming documentation including plans and

specifications, as appropriate, for complex studies.

- Provide advanced technical expertise in conjunction with internal and external clients,

and independently bring project solutions to teams and department, for complex

studies.

- Perform, plan and co-ordinate the development, implementation and validation of new

process technologies, macros and applications.

- Utilize R programming for statistical analyses, data manipulation, reporting,

automation, and development of programming solutions as required by project needs.

- Fulfill project responsibilities at the level of statistical team lead for single complex

studies or group of studies.

- Understand the Scope of Work, budget and quote assumptions, estimate the work

completed, manage Out of Scope and resource forecasts for single studies. May

manage project budget and resource requirements, and provide revenue forecasts for

single studies.

- Provide training and guidance to lower level staff.

📌 Sr. Statistical Programmer (India)
🏢 Acura solutions
📍 India