How you will contribute:
- Acting as a lead programmer on several different projects while being accountable for the quality, traceability, reproducibility and timeliness of statistical programming deliverables
- Be expert solution provider, guide & mentor statistical programmers to develop and manage high performing teams
- Performing data manipulation, analysis and reporting of clinical trial data, both safety and efficacy (ISS/ISE), utilizing SAS programming
- Generating, validating, reviewing SDTM and ADaM datasets/analysis files, and tables, listings, and figures ( TLFs)
- Production and QC / validation programming
- Generating complex ad-hoc reports utilizing raw data
- Applying strong understanding/experience of Efficacy analysis
- Generating, validating, reviewing submission packages
- Communicating with and/or responding to internal cross-functional teams and client for project specifications, status, issues or inquiries
- Willingness to go the extra distance to get results, meet deadlines, etc.
- Being adaptable and flexible when priorities change
What you offer:
- Bachelor's degree in one of the following fields Statistics, Computer Science, Mathematics, etc.
- At least 10 years of SAS programming working with clinical trial data in the Pharmaceutical & Biotech industry with a bachelor's degree or equivalent. At least 8 years of related experience with a master's degree or above.
- Consistent experience as a lead statistical programmer on several concurrent projects
- Strong SAS data manipulation, analysis and reporting skills.
- Solid experience implementing the latest CDISC SDTM / ADaM standards.
- Strong QC / validation skills.
- Good ad-hoc reporting skills.
- Proficiency in Efficacy analysis.
- Familiarity with drug development life cycle and experience with the manipulation, analysis and reporting of clinical trials' data.
- Submissions experience utilizing define.xml and other submission documents.
- Experience supporting GI, Rare diseases, Hematology studies is a plus.
- 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.
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.Cytel does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Cytel's human resources department to obtain prior written authorization before referring any candidates to Cytel. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and Cytel. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of Cytel. Cytel shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies.