Senior Statistical Programmer India FSP

Sponsor-dedicated:

Working fully embedded within one of our pharmaceutical clients, with the support of Cytel right behind you, you'll be at the heart of our client's innovation. As a Statistical Programmer II you will be dedicated to one of our global pharmaceutical clients; a company that is driving the next generation of patient treatment, where individuals are empowered to work with autonomy and ownership.

As a Senior 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.

• 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

• 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.

Cytel Inc. is an Equal Employment / Aff­irmative Action Employer. Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other characteristics protected by law.