Senior Statistical Programmer — Columbia, SC at Cytel

About the Team and Mission

Cytel is dedicated to applying scientific rigor to reveal the full promise inherent in data. We nurture intellectual curiosity, encouraging our team to approach new challenges with enthusiasm and a desire for discovery. Our culture prizes innovation, seeking intelligent solutions using leading-edge technology, and we believe in collaboration by inviting a diversity of perspectives to create a wealth of possibilities.

About the Role

This is a sponsor-dedicated position where you will work fully embedded within one of our global pharmaceutical clients. As a Senior Statistical Programmer, you will be at the heart of the client's innovation, supporting or leading Early and Late-stage clinical trials. This role offers a unique opportunity to drive the next generation of patient treatment while enjoying the autonomy and ownership to shape your work.

You will leverage advanced SAS programming skills and proficiency in CDISC standards (SDTM & ADaM) to generate and validate statistical programming deliverables. Your day-to-day will involve performing data manipulation, analysis, and reporting of clinical trial data (both safety and efficacy), creating complex ad-hoc reports, and reviewing submission documents. You will serve as a team player, communicating with cross-functional teams and the client to manage project specifications and status, while adapting to changing priorities to meet critical deadlines.

Hiring Process

To be successful in this position, candidates must demonstrate a strong background in clinical trial data programming. The selection process focuses on verifying expertise in Early Development studies, including programming for clinical endpoint data (efficacy and safety) and pharmacokinetic data. We look for individuals who can design complex programming algorithms and develop global programming standards for ADaM datasets, efficacy analysis, and safety reporting.

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.

Location and Support

This role is hybrid and office-based in Pennsylvania (preferred) or New Jersey. While embedded with the client, you will have the full support of Cytel behind you. We enable employee success through consistent training, development, and support.

Work location

Work model: Hybrid

Covenant Road, Barhamville Estates, Columbia, Richland County, South Carolina, 29204, United States

Columbia, South Carolina

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 QC and validation skills
verifiedAbility to work in hybrid office (PA or NJ)

Nice to Have

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

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, 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 Covenant Road, Barhamville Estates, Columbia, Richland County, South Carolina, 29204, 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.

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

About the Team and Mission

About the Role

Hiring Process

Equal Opportunity

Location and Support

Work location

Key Responsibilities

Requirements

Nice to Have

Similar Job Opportunities

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

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

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

Skills, education and keywords

Frequently asked questions about Senior Statistical Programmer FSP-Hybrid 3 days a week in PA a must at Cytel