Associate Principal Scientist, Statistical Programming

Merck & Co.; Rahway (NJ); On-site; USD 100,000 - 130,000; Full time

Benefits offered by this job

Medical, dental, and vision benefits

Retirement benefits

Paid holidays and vacation

Annual bonuses and long-term incentives

Job summary

Merck & Co. is seeking an Associate Principal Scientist in Statistical Programming for their Rahway, NJ location. This role focuses on delivering high-quality statistical programming and analysis for toxicology modeling within their Oncology area.

The ideal candidate should have significant SAS programming experience, strong project management skills, and the ability to lead at a program level. Comprehensive benefits, including medical, dental, and retirement options, are offered to eligible employees.

Qualifications

• 9 years of SAS programming experience in a clinical trial environment with a Bachelor's degree.
• 7 years of SAS programming experience in a clinical trial environment with a Master's degree.
• Strong knowledge of pharmaceutical development processes.

Responsibilities

• Gather and interpret user requirements for statistical programming.
• Lead data stewardship and create modeling data from original sources.
• Produce tables and figures for regulatory submissions.

Skills

SAS programming

Data manipulation

Statistical analysis

Project management

Interpersonal skills

Education

Bachelor's degree in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering, Pharmaceutical Sciences or related field

Master's degree in a related field

Tools

SAS

SAS/MACRO

SAS/GRAPH

Job description

Associate Principal Scientist, Statistical Programming – Rahway, NJ

Provide high quality statistical programming analysis and reporting deliverables for global PK modeling and simulation stakeholders within the Oncology therapeutic area.

Responsibilities

• Gather and interpret user requirements, retrieve the required data, transform the data into modeling‑ready analysis datasets, and develop tables and figures according to the modeling analysis plans.
• Lead the data stewardship and take accountability for the creation of modeling data from original data source(s) to final modeling dataset.
• Act as a key collaborator with modelers, statisticians and other project stakeholders, executing project plans efficiently and overseeing the work of other team members when opportunities arise.
• Programmatically synthesize preclinical/clinical data into analysis‑ready structures from varied data sources.
• Create modeling‑ready datasets by integrating PK, PD and covariate data.
• Produce tables and graphics for inclusion in study reports and regulatory submissions.
• Ensure programmatic traceability from data source to modeling result.
• Support the development of programming standards to enable efficient and high‑quality production of programming deliverables.
• Produce SAS transport files and associated documentation for regulatory submissions.
• Represent statistical programming on process improvement activities.

Education Requirements

• Must have a Bachelor's degree (or US equivalent) in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering, Pharmaceutical Sciences, or related field plus 9 years of SAS programming experience in a clinical trial environment.
• OR Master's degree (or US equivalent) in a related field plus 7 years of SAS programming experience in a clinical trial environment.

Position Requirements

• Significant expertise in SAS and clinical trial programming, including data steps, procedures, SAS/MACRO, SAS/GRAPH; and programming expertise with clinical endpoint data (efficacy and safety) and pharmacokinetic data (raw concentration data, derived PK parameters).
• Ability to design and develop complex programming algorithms; to efficiently manipulate clinical trial datasets including complex data preprocessing, filtering, and manipulation; demonstrated ability to work in an exploratory environment, handling non‑standard data in a variety of formats with minimal requirements.
• Knowledge of pharmaceutical development processes.
• Ability to comprehend analysis plans that describe methodology to be programmed.
• Understanding of statistical or pharmacokinetic terminology and concepts; and ability to implement statistical methods not currently available through commercial software packages.
• Broad knowledge and significant experience in developing analysis and reporting deliverables for R&D projects (data, analyses, tables, graphics, listings).
• Ability to lead at a program level; determine approach, ensure consistency, and direct development of others when opportunities arise; engage key stakeholders.
• Strong project management skills, excellent interpersonal skills, ability to negotiate and collaborate effectively, and excellent written, oral, and presentation skills.

Benefits

We offer a comprehensive package of benefits, including medical, dental, vision, retirement benefits, paid holidays, vacation, and compassionate and sick days. Eligible employees may also receive annual bonuses and long‑term incentives.

Equal Employment Opportunity

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.