Senior Statistical Programmer FSP-Hybrid 3 days a week in PA a must
Not Disclosed•Full-TimeHybrid
location_on1100, H Street Northwest, Downtown, Ward 2, Washington, District of Columbia, 20006, United States
About the Role
This position is a sponsor-dedicated opportunity, placing you fully embedded within one of our global pharmaceutical clients. You will be at the heart of their innovation, driving the next generation of patient treatment while enjoying the autonomy and ownership to shape your work. Supported by Cytel's dedicated resources, you will leverage advanced SAS programming skills and CDISC standards (SDTM & ADaM) to lead or support Early and Late-stage clinical trials.
As a Senior Statistical Programmer, you will navigate the full spectrum of clinical data, from generating and validating statistical deliverables to performing complex data manipulation and analysis for safety and efficacy. This role is designed for those who thrive in a collaborative environment where intellectual curiosity is nurtured and scientific rigor is applied to reveal the full promise inherent in data. You will work across all therapeutic areas, contributing to PK/PD modeling and simulation, creating submission documents, and communicating with cross-functional teams to ensure project success.
This hybrid role is based in Pennsylvania (preferred) or New Jersey. We are looking for individuals who are adaptable, flexible when priorities shift, and willing to go the extra distance to meet deadlines. Whether serving as a team player or stepping into lead duties, your work will directly impact the drug development life cycle and the patients who rely on these treatments.
Our Values
At Cytel, we believe in collaboration and invite a diversity of perspectives to create a wealth of possibilities. We prize innovation, seeking intelligent solutions using leading-edge technology, and encourage everyone to approach new challenges with enthusiasm and a desire for discovery.
Hiring Process
To be successful in this position, candidates must demonstrate a strong background in clinical trial data programming. The selection process focuses on identifying individuals with the technical expertise to develop global programming standards and the analytical skills to troubleshoot complex data issues. We prioritize candidates who can thrive in a globally dispersed team environment with cross-cultural partners.
Equal Opportunity Employer
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
1100, H Street Northwest, Downtown, Ward 2, Washington, District of Columbia, 20006, United States
Washington, District of Columbia
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_circleProduce complex ad-hoc reports utilizing raw clinical trial 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
Requirements
- verifiedBachelor's degree in Statistics, Computer Science, Mathematics, etc.
- verified8+ years SAS programming with clinical trial data (Pharma/Biotech) with Bachelor's or 6+ years with Master's
- verifiedExperience with Early Development studies
- verifiedExpertise in clinical endpoint data (efficacy/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 SAS data manipulation, analysis, and reporting skills
- verifiedStrong QC and validation skills
- verifiedAbility to work in a globally dispersed team
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
A Senior Statistical Programmer FSP-Hybrid 3 days a week in PA a must at Cytel is responsible for the following: 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 Produce complex ad-hoc reports utilizing raw clinical trial data.
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, etc.; 8+ years SAS programming with clinical trial data (Pharma/Biotech) with Bachelor's or 6+ years with Master's; Experience with Early Development studies; Expertise in clinical endpoint data (efficacy/safety) and pharmacokinetic data; Proficiency in CDISC SDTM and ADaM standards; and Knowledge of submission standards (Define.XML, SDRG, aCRF).
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 1100, H Street Northwest, Downtown, Ward 2, Washington, District of Columbia, 20006, 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.