Senior Statistical Programmer FSP

Axio Research

5 - 7 years

7 - 9 Lacs

pune

Posted:22 hours ago| Platform:

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Skills Required

statistical programming computer science pharma xml clinical development iss packaging oncology life sciences sas programming

Work Mode

Work from Office

Job Type

Full Time

Job Description

Position Overview:

As a Senior Statistical Programmer, you will perform programming activities for the creation and validation of SDTM domains by implementing CDISC standards and working on pooled studies ADaM datasets for ISS and submission packages with a focus on Oncology.

To be successful in this position you will have:

At least 5 years of relevant statistical programming experience in a clinical development environment.
BA/BSc or higher degree in Statistics, Mathematics, Computer Science, Life Sciences or other related scientific subjects.
Demonstrates advanced experience with all SAS language, procedures, and options commonly used in clinical trial reporting including the Macro language, BASE SAS, SAS/STAT and SAS/GRAPH.
Ability to implement the latest CDISC SDTM standards (production/validation).
Familiarity with pooled ADaM data such as in an ISS or other pooled studies dataset.
Experience with Oncology is required.
Submissions experience utilizing define.xml and other submission documents such as SDRG or ADRG are required.
Very good oral and written English communication skills.

How you will contribute:

Performing data manipulation, analysis and reporting of clinical trial data, both safety and efficacy, utilizing SAS programming.
Applying your CDISC know-how and proficiency to create and validate safety and efficacy SDTMs.
Creating and validating pooled analysis datasets (ADaMs), tables, listings, and figures (TLFs).
Preparing submission packages, i.e. define.xml, Reviewers Guide, Pinnacle 21.
Generating complex ad-hoc reports.
Serving as team player, with a willingness to go the extra distance to get results, meet deadlines, etc.
Being adaptable and flexible when priorities change.

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