Biostatistician with SAS Programming

Makro Scientific; Bridgewater (MA); On-site; USD 85,000 - 120,000; Full time

Job summary

Makro Scientific is seeking an experienced EBM biostatistician in Bridgewater, Massachusetts for a contract role. The ideal candidate will provide statistical expertise for observational research and ensure adherence to study design and methodologies.

The position involves collaborating on study protocols, performing data analyses, and producing statistical deliverables. Candidates should hold an MS or Ph.D. in Statistics with a minimum of 5 years in pharmaceutical research.

Qualifications

• Minimum 5 years of experience in pharmaceutical research or equivalent.
• Strong understanding and application of biostatistical methods.
• Experience in designing and analyzing observational studies.

Responsibilities

• Provide statistical support for EBM studies focusing on real-world observational studies.
• Develop protocols and statistical analysis plans.
• Conduct data analysis and produce deliverables for research projects.
• Oversee CRO work for biostatistics-related activities.
• Ensure quality control of statistical deliverables.

Skills

Biostatistical analysis

SAS programming

Epidemiology

Health economics

Outcomes research

Excellent communication skills

Observational databases

Education

MS or Ph.D. in Statistics or related field

Job description

Job Description

Duration: 6+ Months

Duties:

The EBM biostatistician provides statistical expertise for all observational research projects sponsored by the Clients US Evidence Based Medicine (EBM) in protocol development, Statistical Analysis Plan (SAP) preparation and study report.

The role ensures the appropriateness of study design, sample size and statistical methodologies are used and adherence to the established standards and SOPs.

The role manages the timely execution of statistical and research methodological components of EBM study protocols to meet project objectives and maintains a thorough understanding of current requirements for statistical standards.

Roles/Responsibilities

• Utilize statistical knowledge and expertise to provide statistical support for EBM studies, with a main focus on real‑world observational studies, database examples: US medical and pharmacy claims databases (e.g., MarketScan); US medical record databases (e.g., GE Healthcare); US government public use databases (e.g., NHANES, MEPS).
• Participate in study concept, protocol and SAP development and ensure appropriateness of study design, sample size and statistical methodologies proposed.
• Specify the structure of the datasets that will be delivered for statistical analysis to ensure that the structure follows any existing company standard for databases pooling.
• Mock‑up, review, and approve tables, listings and graphs specifications.
• Actively participate in project/study team meetings; establish/negotiate timelines for completion of study‑related statistical activities and ensure study timelines are met.
• Conduct observational data analysis, including data management, statistical programming, interpretation of analysis results, and write‑up/review of the corresponding sections of the EBM study report.
• Produce analysis datasets, listings, tables, and figures for research projects according to specifications while maintaining documentation and complying with pre‑defined project/study standards.
• Provide oversight of biostatistics‑related activities for EBM studies subcontracted to a CRO: oversee the CROs work on the preparation of analysis plans, development and validation of computer algorithms for inferential analyses, statistical writing of study reports, and other outsourced analyses as appropriate.
• Perform quality control procedures to ensure that statistical deliverables conform to the requirements outlined in the SAP.

Skills

• Working knowledge and experience with biostatistical analysis and SAS programming.
• Excellent oral and written communication skills in English are a must.
• Prior work experience in epidemiology, health economics and outcomes research, or clinical research area is a plus.
• Specific experience and understanding of outcomes research, drug development is an asset. Familiarity with observational databases desirable.

Education

MS or Ph.D. in Statistics or related field. Minimum 5‑year experience in pharmaceutical research or equivalent.

Job Type

Contract.