Senior Statistical Programmer — Augusta, ME at Cytel

About the Role

You will be fully embedded within one of our global pharmaceutical clients, serving as a Senior Statistical Programmer at the heart of their innovation. This sponsor-dedicated position offers a unique opportunity to work with autonomy and ownership on the next generation of patient treatments, 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. The role involves generating and validating statistical programming deliverables across all therapeutic areas, including Early Development Statistics and PK/PD Modeling and Simulation. You will perform data manipulation, analysis, and reporting for both safety and efficacy, while also creating complex ad-hoc reports and reviewing submission documents.

This is an exciting time to join a team that values scientific rigor, intellectual curiosity, and collaboration. We encourage a diversity of perspectives to create intelligent solutions using leading-edge technology. You will work effectively in a globally dispersed team environment, adapting to changing priorities while meeting challenging deadlines.

Location

This role is hybrid and office-based in Pennsylvania (preferred) or New Jersey.

Our Values

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 the desire for discovery.
We believe in collaboration and invite a diversity of perspectives, drawing on a variety of talents to create a wealth of possibilities.
We prize innovation and seek intelligent solutions using leading-edge technology.

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

122, Sparrow Drive, Riverside Drive Village, Augusta, Kennebec County, Maine, 04330, United States

Augusta, Maine

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_circleProduce and perform QC/validation programming for clinical trial data

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.

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 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

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 122, Sparrow Drive, Riverside Drive Village, Augusta, Kennebec County, Maine, 04330, 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 Role

Location

Our Values

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