Cytel provides unrivalled biostatistics and operations research to improve drug development success rates, crucial for human welfare. Focused on using innovative applications of statistical science and adaptive clinical trial design, Cytel is at the cutting edge of technology and human ingenuity, driving healthcare forward.
We are seeking Senior/ Principal Statistical Programmers for our growing FSP division. You will report to the Senior Director, Statistical Programming.
This is a home-based position in Europe, with the option to work from our Geneva, Basel, Paris and Barcelona office locations.
As a Senior / Principal 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.
- 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 trials’ data.
- Strong SAS data manipulation, analysis and reporting skills.
- Ability to implement the latest CDISC SDTM / ADaM standards (production/validation). ADaM efficacy dataset development is required.
- Familiarity with pooled data such as in an ISS or ISE or other pooled studies dataset. Experience is preferred but not required.
- Proficiency in SAS MACRO development
- Strong ad-hoc reporting
- Solid experience in Efficacy analysis
- Experience and or familiar with Pinnacle21
- Submissions experience utilizing define.xml and other submission documents such as SDRG, ADRG
- Experience supporting Medical Affairs, Immunology, Cardiovascular, Oncology, Infectious Disease strongly desirable.
- Excellent analytical & troubleshooting skills.
- Ability to provide quality output and deliverables, in adherence with challenging timelines.
- Ability to work effectively and successfully in a globally dispersed team environment with cross-cultural partners.
- Our collaborative working environment encourages innovation and rewards results, and we are proud to have one of the lowest turnover rates in the industry.
- In addition to a competitive compensation, we offer an excellent benefit’s package, annual bonus incentive, promote work-life balance, and the opportunity to grow with us!
- Work with respected experts and thought leaders in the fields of biostatistics and statistical programming.