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  5. Senior Statistical Programmer FSP-Hybrid 3 days a week in PA a must
Cytel logo

Senior Statistical Programmer FSP-Hybrid 3 days a week in PA a must

Not Disclosed•Full-TimeHybrid

location_onPeachtree Circle Northeast, Atlanta, Fulton County, Georgia, 30309, United States

Apply Now

About the Role

You will work fully embedded within one of our global pharmaceutical clients, serving as a Senior Statistical Programmer dedicated to driving the next generation of patient treatment. This position offers a unique opportunity to work with autonomy and ownership at the heart of a client's innovation, supported by Cytel's expertise behind you. As part of this new program, you will leverage advanced SAS programming skills and proficiency in CDISC standards (SDTM & ADaM) to support or lead early or late-stage clinical trials.

This role is hybrid and office-based in Pennsylvania (preferred) or New Jersey. You will be part of a team that believes in applying scientific rigor to reveal the full promise inherent in data, nurturing intellectual curiosity, and approaching new challenges with enthusiasm. We value collaboration and a diversity of perspectives, seeking intelligent solutions using leading-edge technology to create a wealth of possibilities.

How You Will Contribute

In this position, you will generate and validate statistical programming deliverables, including SDTM, ADaM, and TFLs, spanning all therapeutic areas in Early Development Statistics and PK/PD Modeling and Simulation. Your day-to-day will involve performing data manipulation, analysis, and reporting of clinical trial data (both safety and efficacy), as well as handling production and QC/validation programming. You will also create complex ad-hoc reports from raw data, apply strong understanding of efficacy analysis, and assist in creating and reviewing submission documents and eCRTs.

Beyond technical execution, you will communicate with internal cross-functional teams and the client regarding project specifications, status, and inquiries. You are expected to perform lead duties when called upon, serve as a dedicated team player willing to go the extra distance to meet deadlines, and remain adaptable when priorities shift.

Our Commitment to Success

At Cytel, we want our employees to succeed and enable this through consistent training, development, and support. We strive to create an environment where individuals can thrive while contributing to meaningful scientific discoveries.

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

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Senior Statistical Programmer FSP-Hybrid 3 days a week in PA a must

Cytel • Cambridge, Massachusetts

Not Disclosedarrow_forward
Cytel logo

Senior Statistical Programmer FSP-Hybrid 3 days a week in PA a must

Cytel • Hybrid

Not Disclosedarrow_forward
Cytel logo

Senior Statistical Programmer FSP-Hybrid 3 days a week in PA a must

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 (preferred for 6 years experience).

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
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 in Pharma/Biotech (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?
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Peachtree Circle Northeast, Atlanta, Fulton County, Georgia, 30309, United States

Atlanta, Georgia

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, or related field
  • verified8+ years SAS programming with clinical trial data in Pharma/Biotech (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 QC and validation skills
  • verifiedAbility to work in a hybrid office setting in PA or NJ

Nice to Have

Experience with R, SPlus, or NonMem. Experience supporting Oncology studies.

Cytel logo
Company

Cytel

Industry

scientific & qa

View company profilearrow_forwardlanguageWebsite
Quick Overview

Experience

8+ yrs (Senior)

Education

Bachelor's degree in Statistics, Computer Science, Mathematics, etc.

Job Type

Full-Time

Skills Required

SasCdiscSDTMAdamPK/PD Modeling And SimulationEfficacy Analysis

Cytel • Providence, Rhode Island

Not Disclosedarrow_forward
expand_more
Senior Statistical Programmer FSP-Hybrid 3 days a week in PA a must at Cytel is based in Peachtree Circle Northeast, Atlanta, Fulton County, Georgia, 30309, 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 (preferred for 6 years experience).
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.
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Safety Analysis
R
Splus
Nonmem