Senior Statistical Programmer – SDTM
Company Name:-
Cytel, India
Job Location:-
India
Job Summary:-
At Cytel, we work hard to create successful careers with significant professional growth for our employees, as a result of which they work hard to make Cytel successful.
Cytel is a place where talent, experience and integrity come together to advance the state of clinical development.
As a Senior SDTM Statistical Programmer, you will leverage your advanced SAS programming skills and proficiency in CDISC standards (SDTM & ADaM) to support or lead one or more Phase I-IV clinical trials, with a focus on any of the following studies; Immunology, Oncology, Cardiovascular, Infectious Disease, Early Development, or Medical Affairs.
In-depth knowledge of data structures and relevant programming languages for data manipulation and reporting.
Knowledge of SAS is required, may include SAS, R, Python, etc.
.
Expert knowledge of Define.
xml, SDTM aCRF, cSDRGs.
Expert knowledge of data structures (e.
g.
, CDISC SDTM, CDISC CT) and their implementation.
Experience in working with SDTM Conformance Checks
SDTM mapping
Technical Data Management experience and experience working on a clinical trial.
3-5 years experience
Performing data manipulation, analysis and reporting of clinical trial data, both safety and efficacy, utilizing SAS programming;
Applying your CDISC know-how and proficiency in SDTM and ADaM, to create and validate datasets/analysis files, tables, listings, and figures ( TLF s);
Generating complex ad-hoc reports
Preparing and validating submission packages, i.
e.
define.
xml, Reviewers Guide
Applying your strong understanding/experience with Efficacy analysis;
Preparing submission packages
Performing lead duties when called upon;
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
Qualifications and Experience:
BSc/ MSC degree or equivalent, preferably in a scientific discipline such as Statistics, Computer Science, Mathematics, etc.
Must have relevant industry experience
Familiarity with drug development life cycle and experience with the manipulation, analysis and reporting of clinical trialsÂ’ data.
Strong SAS data manipulation, analysis and reporting skills.
Ability to implement the latest CDISC SDTM / ADaM stand
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