Senior Statistical Programmer — Nashville, TN at Cytel

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. You will leverage advanced SAS programming skills and proficiency in CDISC standards (SDTM & ADaM) to support or lead Early and Late-stage clinical trials.

This is a hybrid role based in Pennsylvania (preferred) or New Jersey. The environment is designed for those who believe in applying scientific rigor to reveal the full promise inherent in data, nurturing intellectual curiosity and encouraging a desire for discovery. We value collaboration and a diversity of perspectives, seeking intelligent solutions using leading-edge technology to create a wealth of possibilities.

Hiring Process

To be successful in this position, candidates must demonstrate a strong background in clinical trial data manipulation, analysis, and reporting. The role requires a deep understanding of the drug development life cycle and the ability to work effectively in a globally dispersed team environment with cross-cultural partners. We look for individuals who are adaptable, flexible when priorities change, and willing to go the extra distance to meet 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

1504, Hawkins Street, Nashville, Davidson County, Middle Tennessee, Tennessee, 37203, United States

Nashville, Tennessee

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, etc.
verified8+ years SAS programming with clinical trial data (Pharma/Biotech) with Bachelor's or equivalent
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 based in 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

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

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 equivalent; 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 1504, Hawkins Street, Nashville, Davidson County, Middle Tennessee, Tennessee, 37203, 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

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

About the Role

Hiring Process

Equal Opportunity

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