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.

Position Overview:

As a Senior Statistical Programmer, you will perform programming activities for the creation and validation of SDTM (including efficacy SDTMs ) as well as ADaM domains by implementing CDISC standards and working on pooled studies ADaM datasets for ISS and submission packages with a focus on Oncology. ISS and ADaM knowledge are a must have.

ShortDescriptionStr

Our commitment to developing our staff is only surpassed by our commitment to advancing treatment options available to patients. At Cytel, we work hard to create successful careers with significant professional growth for our employees and as a result work hard to make Cytel successful. Cytel is a place where talent, experience, and integrity come together to advance the state of clinical development.

- 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).
- Working knowledge with pooled ADaM data such as in an ISS or other pooled studies dataset.

- Recent experience with Oncology is required .

- Submissions experience of creating define.xml and other submission documents such as sSDRG or ADRG are required .
- Very good oral and written English communication skills.

InternalQualificationsStr





- 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).
- Working knowledge with pooled ADaM data such as in an ISS or other pooled studies dataset.

- Recent experience with Oncology is required .

- Submissions experience of creating define.xml and other submission documents such as sSDRG or ADRG are required .
- Very good oral and written English communication skills.

InternalResponsibilitiesStr

How you will contribute:

- Performing data 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.

ExternalResponsibilitiesStr

How you will contribute:

- Performing data 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 versatile when priorities change.

📌 Senior Statistical Programmer FSP (India)
🏢 Cytel
📍 India