Statistical Programmer

7 days ago

Remote, India Element Technologies inc Full time

Roles and responsibilities - Primarily responsible for quality and timely delivery of ADaM artifacts (Specifications, datasets, ADRG) and TFLs

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

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)

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

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

Develop, Debug Utility macros for reusability and efficiency

Customer & Delivery Management
- Support & Supervise Programming team towards resolving study/program related issues and thereby efficiently meet all project timelines & deliver quality outputs.
- Respond to queries raised by sponsor/regulators
- Communicate with project team/stakeholders/ other departments and/or groups effectively Skills
- Experience working on ADAM and TFL deliverables on multiple therapeutic areas and phases in clinical trials.
- Experience creating and working with Utility Macros
- Experience creating specifications
- Experience with CDSIC standards including CDASH or SDTM/ADaM
- Ability to work independently and as part of a team
- Being open to new learnings and sharing with team members
- Excellent communication skills [Written, Verbal, Interpersonal and organizational skills]
- Proficient in using SAS EG/Studio for programming
- Familiar with Unix environment and programming

**Some Oncology skills need to be checked as well -**

**Hazard ratios**

**ADRSObjective response rate**

**Diff time to progression**

**Adjudication of response**

**Nadir**

**Job Types**: Full-time, Permanent

Pay: ₹308,880.47 - ₹1,205,968.47 per year

Work Location: Remote

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