Senior Statistical Programmer FSP

Cytel - USA & APAC; South Africa; Hybrid; ZAR 600 000 - 900 000; Full time

Job summary

A leading company in the pharmaceutical sector is seeking a Senior Statistical Programmer to support clinical trials. This hybrid role requires advanced SAS programming skills and a strong understanding of CDISC standards. The successful candidate will be responsible for generating statistical programming deliverables, performing data analysis, and collaborating with internal teams. This is an exciting opportunity to be part of innovative patient treatment initiatives.

Qualifications

• Minimum of 8 years SAS programming experience with clinical trial data.
• Experience with Early Development studies and programming for clinical efficacy.
• Strong skills in SAS data manipulation, analysis, and reporting.

Responsibilities

• Generating and validating statistical programming deliverables for clinical trials.
• Performing data manipulation, analysis, and reporting of clinical trial data.
• Leading project duties and communicating with internal teams.

Skills

SAS programming

CDISC standards

data manipulation

efficacy analysis

ad-hoc reporting

Education

Bachelor’s degree in Statistics, Computer Science, Mathematics

Tools

R

SPlus

NonMem

Pinnacle 21 Enterprise

Job description

JOB DESCRIPTION

Sponsor-dedicated:

Working fully embedded within one of our pharmaceutical clients, with the support of Cytel right behind you, you'll be at the heart of our client's innovation. As a Senior Statistical Programmer, you will be dedicated to a global pharmaceutical company that is driving the next generation of patient treatment, empowering individuals to work with autonomy and ownership. This is an exciting time to be part of this new program.

Position Overview:

As a Senior Statistical Programmer, leverage your advanced SAS programming skills and proficiency in CDISC standards (SDTM & ADaM) to support or lead one or more clinical trials, either in Early or Late stages. This role is hybrid, based in PA (preferred) or NJ.

Our values:

• Applying scientific rigor to data to reveal its full potential.
• Nurturing intellectual curiosity and encouraging new challenges.
• Promoting collaboration and valuing diverse perspectives.
• Seeking innovation and intelligent solutions using cutting-edge technology.

Responsibilities:

• Generating and validating statistical programming deliverables (SDTM, ADaM, TFLs) for Early Development Statistics and PK/PD Modeling across therapeutic areas.
• Performing data manipulation, analysis, and reporting of clinical trial data, including safety and efficacy data (ISS/ISE), using SAS.
• Producing and validating programming outputs.
• Creating complex ad-hoc reports from raw data.
• Applying strong understanding and experience in efficacy analysis.
• Creating and reviewing submission documents and eCRFs.
• Communicating with internal teams and clients regarding project specifications, status, issues, or inquiries.
• Leading project duties when required.
• Being a team player, willing to go the extra mile to meet deadlines and achieve results.
• Adapting flexibly to changing priorities.

Qualifications:

• Bachelor’s degree in Statistics, Computer Science, Mathematics, or related fields.
• Minimum of 8 years SAS programming experience with clinical trial data in the Pharmaceutical & Biotech industry, with a bachelor’s degree or equivalent; at least 6 years with a master’s degree or higher.
• Experience working on Early Development studies, including programming for clinical efficacy, safety, and pharmacokinetic data.
• Developing and validating global programming standards for ADaM datasets, efficacy, and safety analyses.
• Designing and developing complex programming algorithms.
• Experience with R, SPlus, NonMem is preferred.
• Supporting SDTM deliverables for analysis, reporting, and submission, including use of Pinnacle 21 Enterprise.
• Experience with SDTM versioning activities.
• Experience supporting Oncology studies is a plus.
• Strong skills in SAS data manipulation, analysis, and reporting.
• Implementing latest CDISC SDTM / ADaM standards.
• Knowledge of submission standards such as Define.XML, SDRG, aCRF.
• Excellent QC/validation skills.
• Proficiency in ad-hoc reporting and efficacy analysis.
• Understanding of drug development lifecycle and clinical trial data management.
• Experience with submission documents and troubleshooting skills.
• Ability to produce high-quality outputs within tight deadlines.
• Effective team collaboration skills, especially in a global, cross-cultural environment.