Senior Statistical Programmer FSP-Hybrid 3 days a week in PA a must
Not Disclosed•Full-TimeHybrid
location_onGranchina, Calle Guayama, 00917, United States
About the Role
You will be fully embedded within one of our global pharmaceutical clients, serving as a Senior Statistical Programmer at the heart of their innovation. This sponsor-dedicated position offers a unique opportunity to work with autonomy and ownership on the next generation of patient treatments. Supported by Cytel's internal expertise, you will drive the statistical programming for Early or Late-stage clinical trials, leveraging advanced SAS skills and CDISC standards (SDTM & ADaM) to reveal the full promise inherent in data.
This role is hybrid and based in Pennsylvania (preferred) or New Jersey. You will collaborate with cross-functional teams and the client to define project specifications, manage status updates, and resolve inquiries. As a team player, you will be expected to adapt to shifting priorities and go the extra distance to meet critical deadlines.
Our Values
At Cytel, we believe in applying scientific rigor to data and nurturing intellectual curiosity. We approach new challenges with enthusiasm and a desire for discovery. We prize collaboration and a diversity of perspectives to create a wealth of possibilities, while seeking intelligent solutions using leading-edge technology.
Hiring Process
To be successful in this position, candidates must demonstrate a strong background in clinical trial data manipulation, analysis, and reporting. The selection process evaluates technical proficiency in SAS, adherence to CDISC standards, and the ability to work effectively in a globally dispersed team environment.
Equal Opportunity
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.
Work location
Work model: Hybrid
Granchina, Calle Guayama, 00917, United States
Key Responsibilities
- check_circlePerform data manipulation, analysis, and reporting of clinical trial safety and efficacy data using SAS
- check_circleDevelop and validate global programming standards for ADaM datasets and efficacy analysis
- check_circleDesign and develop complex programming algorithms for clinical endpoint and pharmacokinetic data
- check_circleGenerate and validate statistical programming deliverables including SDTM, ADaM, and TFLs
- check_circleCollaborate with cross-functional teams and clients to address project specifications and inquiries
- check_circleCreate and review submission documents and eCRTs for regulatory filings
- check_circleProduce complex ad-hoc reports utilizing raw data to support project needs
Requirements
- verifiedBachelor's degree in Statistics, Computer Science, Mathematics, or related field
- verified8+ years SAS programming with clinical trial data (Pharma/Biotech) with Bachelor's degree
- verified6+ years related experience with Master's degree or above
- verifiedExperience with Early Development studies
- verifiedExpertise in clinical endpoint data (efficacy and safety) and pharmacokinetic data
- verifiedProficiency in CDISC SDTM and ADaM standards
- verifiedKnowledge of submission standards (Define.XML, SDRG, aCRF)
- verifiedExperience with Pinnacle 21 Enterprise
- verifiedStrong QC and validation skills
- verifiedAbility to work in hybrid office location (PA or NJ)
Nice to Have
Experience with R, SPlus, or NonMem. Experience supporting Oncology studies.
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Skills, education and keywords
Skills: Sas, Cdisc, SDTM, Adam, PK/PD Modeling And Simulation, Efficacy Analysis, Safety Analysis, R, Splus, Nonmem.
Education: Bachelor's degree in Statistics, Computer Science, Mathematics, etc.; Master's degree or above (reduces experience requirement to 6 years).
Frequently asked questions about Senior Statistical Programmer FSP-Hybrid 3 days a week in PA a must at Cytel
What does a Senior Statistical Programmer FSP-Hybrid 3 days a week in PA a must at Cytel do?expand_more
In this Senior Statistical Programmer FSP-Hybrid 3 days a week in PA a must at Cytel role, you will perform data manipulation, analysis, and reporting of clinical trial safety and efficacy data using sas; develop and validate global programming standards for adam datasets and efficacy analysis; design and develop complex programming algorithms for clinical endpoint and pharmacokinetic data; and generate and validate statistical programming deliverables including sdtm, adam, and tfls.
What are the requirements for this Senior Statistical Programmer FSP-Hybrid 3 days a week in PA a must role?expand_more
Cytel is looking for candidates who meet the following requirements: Bachelor's degree in Statistics, Computer Science, Mathematics, or related field; 8+ years SAS programming with clinical trial data (Pharma/Biotech) with Bachelor's degree; 6+ years related experience with Master's degree or above; Experience with Early Development studies; Expertise in clinical endpoint data (efficacy and safety) and pharmacokinetic data; and Proficiency in CDISC SDTM and ADaM standards.
Where is the Senior Statistical Programmer FSP-Hybrid 3 days a week in PA a must role at Cytel located?expand_more
Senior Statistical Programmer FSP-Hybrid 3 days a week in PA a must at Cytel is based in Granchina, Calle Guayama, 00917, United States. This is a hybrid role.
Is this Senior Statistical Programmer FSP-Hybrid 3 days a week in PA a must job remote, hybrid, or on-site?expand_more
Cytel has listed this Senior Statistical Programmer FSP-Hybrid 3 days a week in PA a must role as hybrid.
How much experience is required for this Senior Statistical Programmer FSP-Hybrid 3 days a week in PA a must role?expand_more
Senior Statistical Programmer FSP-Hybrid 3 days a week in PA a must at Cytel typically requires 8+ years of relevant experience at the senior level.
What skills do you need for the Senior Statistical Programmer FSP-Hybrid 3 days a week in PA a must role at Cytel?expand_more
Key skills for Senior Statistical Programmer FSP-Hybrid 3 days a week in PA a must at Cytel include Sas; Cdisc; SDTM; Adam; PK/PD Modeling And Simulation; Efficacy Analysis; Safety Analysis; and R.
What education is required for Senior Statistical Programmer FSP-Hybrid 3 days a week in PA a must at Cytel?expand_more
Educational requirements for this role: Bachelor's degree in Statistics, Computer Science, Mathematics, etc.; and Master's degree or above (reduces experience requirement to 6 years).
What category does the Senior Statistical Programmer FSP-Hybrid 3 days a week in PA a must role belong to?expand_more
Senior Statistical Programmer FSP-Hybrid 3 days a week in PA a must at Cytel is part of the scientific & qa job category on Recrutus.