Senior Statistical Programmer FSP-Hybrid 3 days a week in PA a must
Not Disclosed•Full-TimeHybrid
location_onWest Carnoustie Road, Fox Hall West, Dover, Kent County, Delaware, 19904, United States
About the Role
This position is sponsor-dedicated, placing you fully embedded within one of our global pharmaceutical clients. As a Senior Statistical Programmer, you will be at the heart of their innovation, supporting or leading Early and Late-stage clinical trials. You will work with autonomy and ownership, empowered to drive the next generation of patient treatment, with the full support of Cytel behind you.
This is an exciting opportunity to join a new program where you will leverage advanced SAS programming skills and proficiency in CDISC standards (SDTM & ADaM) to generate and validate statistical programming deliverables. The role spans all therapeutic areas, including Early Development Statistics and PK/PD Modeling and Simulation, requiring you to perform data manipulation, analysis, and reporting for both safety and efficacy.
Our Values
At Cytel, we believe in applying scientific rigor to reveal the full promise inherent in data. We nurture intellectual curiosity and encourage everyone to approach new challenges with enthusiasm and a desire for discovery. We believe in collaboration, inviting a diversity of perspectives to create a wealth of possibilities, and we prize innovation by seeking intelligent solutions using leading-edge technology.
Work Environment
This role is hybrid and office-based, preferably located in Pennsylvania (PA) or New Jersey (NJ). You will work effectively in a globally dispersed team environment with cross-cultural partners, adapting to changing priorities while meeting challenging deadlines.
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
West Carnoustie Road, Fox Hall West, Dover, Kent County, Delaware, 19904, United States
Dover, Delaware
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 complex ad-hoc reports utilizing raw clinical trial data
- check_circleGenerate and validate statistical programming deliverables including SDTM, ADaM, and TFLs
- check_circleCommunicate with cross-functional teams and clients regarding project specifications and status
- check_circleCreate and review submission documents and eCRTs for regulatory filings
- check_circlePerform production and QC/validation programming to ensure data accuracy
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
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 Generate 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
To qualify for the Senior Statistical Programmer FSP-Hybrid 3 days a week in PA a must at Cytel position, applicants should have: 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 West Carnoustie Road, Fox Hall West, Dover, Kent County, Delaware, 19904, 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.