Statistician/Programmer

cGxPServe Inc.; Woodbridge Township (NJ); On-site; USD 100,000 - 110,000; Full time

Job summary

cGxPServe Inc. is seeking a Consultant Statistician/Programmer to support Real-World Evidence and Health Economics initiatives. The role involves extensive collaboration with biostatisticians to develop statistical programs, ensuring compliance with industry standards, while also maintaining documentation and audit trails.

Qualifications

• Minimum 4 years of experience in clinical research, preferably with a pharmaceutical CRO.
• Hands-on experience with CDISC SDTM and Adam datasets.

Responsibilities

• Develop and validate statistical programs using SAS and/or R.
• Generate high-quality tables and figures based on clinical trial data.
• Perform quality control on statistical programs and outputs.

Skills

Statistical programming

Analytical skills

Problem-solving

Education

Master's degree in Statistics, Biostatistics, Mathematics, Computer Science

Tools

SAS

R

Job description

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Job Description

We are seeking a highly skilled and detail-oriented Consultant Statistician/Programmer to support Real-World Evidence (RWE) and Health Economics and Outcomes Research (HEOR) initiatives. The successful candidate will work closely with the RWE/HEOR biostatistician and will be responsible for developing, executing, and validating statistical programs using SAS and/or R to support analyses and deliverables for RWE, HEOR, and Market Access activities.

Job Description

We are seeking a highly skilled and detail-oriented Consultant Statistician/Programmer to support Real-World Evidence (RWE) and Health Economics and Outcomes Research (HEOR) initiatives. The successful candidate will work closely with the RWE/HEOR biostatistician and will be responsible for developing, executing, and validating statistical programs using SAS and/or R to support analyses and deliverables for RWE, HEOR, and Market Access activities.

Responsibilities

• Collaborate with HEOR and RWE biostatisticians to provide statistical programming support across various projects.
• Develop, validate, and maintain SAS and/or R programs to support statistical analyses and reporting activities for HEOR, RWE, and Market Access studies.
• Generate high-quality tables, listings, and figures based on clinical trial data and other relevant data sources.
• Perform statistical modelling and analyses as required.
• Utilize SDTM and Adam datasets to derive analysis datasets.
• Serve as the primary programmer on assigned projects, ensuring that programming deliverables are accurate and consistent.
• Perform quality control (QC) on statistical programs and outputs as needed.
• Ensure all programming activities comply with industry standards, study protocols, and statistical analysis plans (SAPs).
• Provide input on statistical methodologies and contribute to project deliverables.
• Maintain comprehensive documentation and audit trails for all programming activities.
• Perform rigorous data quality checks to ensure accuracy, completeness, and consistency.
  

Requirements

• Master's degree in Statistics, Biostatistics, Mathematics, Computer Science, or a related technical discipline.
• Minimum of 4 years of experience in clinical research, preferably within the pharmaceutical or CRO industry, with exposure to Phase I IV trials.
• Hands-on experience with CDISC SDTM and Adam datasets.
• Proficiency in SAS and R programming is required.
• Strong analytical and problem-solving skills, with the ability to manage complex studies and meet deadlines.
• Experience with statistical techniques, including longitudinal data analysis, survival analysis, and statistical modelling/simulation.
• Familiarity with observational studies, causal inference, patient-reported outcomes (PROs), and health technology assessment (HTA).
• Experience with indirect treatment comparisons (ITCs), such as matching-adjusted indirect comparison (MAIC), is a plus.
• Prior experience in a similar role within the pharmaceutical industry, preferably with a focus on small molecule pharmaceuticals.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Research, Analyst, and Information Technology

• Industries

  Research Services

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