Job Description

Role Name: Sr. Statistical Programming/Principle Statistical Programming

Location: Hyderabad Hybrid

It\'s an individual contributor role

Mandate Requirements

SDTM Datasets

ADaM-Datasets

TLF (Tables, Listings and Figures/Graphs)

4 years of relevant experience for SSP

8 years of relevant experience for PSP

Roles and Responsibilities

The Statistical Programming team is a dynamic function where we are empowered to experiment, explore and progress beyond the boundaries of best-in-class Statistical Programming analysis. From a collaborative effort with Data Management, Clinical Study Teams, Statisticians, medical / scientific writing teams, publication teams, we analyze tons of data, deriving meaningful insights that enable us to deliver innovative medicines to millions of patients worldwide.

Your responsibilities include, but are not limited to:

- Lead and coordinate activities of all statistical programmers as Trial Programmer for phase I to IV clinical studies or assigned project-level activities. Make statistical programming recommendations at study level.

- Build and maintain effective working relationship with cross-functional teams, discuss status of deliverables and critical programming aspects (timelines, scope), e.g., as member of the Clinical Trial Team (CTT).

- Review eCRF, discuss data structures and participate in data review activities in accordance with the company, department and industry standards (e.g., CDISC). Processes, review and develop programming specifications as part of the analysis plans.

- Provide input into statistical programming solutions and/or ensure their efficient implementation.

- Responsible for development of programming specifications of analysis datasets and pooled datasets.

- Ensuring timely and quality development and validation of datasets and outputs for CSRs, regulatory submissions/interactions, safety reports, publications or exploratory analyses (as required) in the assigned drug development study/project according to specifications.

- Establish successful working relationships on individual studies with external associates according to agreed contract and internal business guidelines. Contributes to assigned parts of process improvement, standardisation and other non-clinical initiatives.

- BA/BS/MS or international equivalent experience in statistics, computer science, mathematics, life sciences or related field with Ideally 5+years of work experience in a programming role preferably supporting clinical trials/or in pharmaceutical industry.

- At least 5 years\' work experience in a programming role preferably supporting clinical trials/ or in the pharmaceutical industry (3 years for MS Statistics / Computer Science graduates with sound understanding of CDISC SDTM and ADaM standards).

- Good SAS experience and proven skills in the use of SAS within a Statistical Programming environment to develop and validate deliverables. Good experience in contributing to statistical analysis plans and/or constructing technical programming specifications.

- Good knowledge of industry standards including CDISC data structures as well as understanding of the development and use of standard programs. Good understanding of regulatory requirements relevant to Statistical Programming (e.g. GCP, study procedures).

- Good communications and negotiation skills, ability to work well with others globally

IIM Jobs