Department of Statistics

Statistics Jobs

Research Data Analyst
BioStat Solutions, Inc. (BSSI)

Company Information: BioStat Solutions, Inc. (BSSI) is a statistical consulting corporation in service to the pharmaceutical, biotechnology and biodefense industries. BSSI’s key service areas include the development and implementation of analytical strategies for biomarker studies, biodefense countermeasure development, and medical device / (companion) diagnostic studies.

Position Title: Research Data Analyst

Duties and Responsibilities: Location: Raleigh/Durham, NC

Job Objective:

Assemble data sets in accordance with regulatory standards, prepare data for statistical analysis, perform statistical analysis, apply statistical methodology in accordance with project requirements and generate reports in support of BSSI’s key service areas, working in conjunction with Statisticians and Statistical Analysts under the guidance of BSSI Associate Directors.

Job Details:
o Assemble data sets into EXCEL spread sheets generated by QC assay systems and prepare them for statistical Analysis – Sources of data sets will include LABWARE LIMS data queries and QC Laboratory log books
o Work in an independent manner but understand when to escalate questions.
o Interact with area management and scientists to gain information in a collaborative, respectful manner while utilizing cGMP understanding and experience
o Assist Statisticians and Statistical Analysts by providing statistical analysis in major therapeutic areas and diseases
o Collaborate with team members towards achieving clients’ objectives
o Conduct work in accordance with Standard Operating Procedures (SOPs), QA/QC Policies, client-specific requirements and applicable regulatory guidelines
o Data analysis and reporting
o Power and sample size calculations
o Preparation of analysis data sets for Associate Directors, Statisticians and Statistical Analysts
o Create programs as directed by leadership to generate summary reports for presentation and interpretation of results in accordance with project requirements
o Assist in development of documents or presentations as needed
o Validate statistical results with team members to ensure high quality deliverables
o Participate in internal research and development activities as needed

Position Qualifications: o BS or MS REQUIRED. Preferred degree in Biostatistics
o Data query experience with validated QC laboratory data systems such as LABWARE LIMS, including interactions and experience with data, up to the level of data query construction.
o Experience working in a cGMP or similar type or regulatory environment, cGLP, etc…
o Experience with oversight of CQ laboratory data in respect to analytical test methods/assays
o Experience in preparing data sets to the quality level required for statistical analysis and cGMP decision making
o Proficiency in SAS or R programming is required; Proficiency in both is preferred
o Experience in application of statistics to biological systems or genetics is preferred
o Proven ability to work independently and in a team environment
o Excellent attention to detail and accuracy in data reporting, along with excellent analytical and problem-solving skills
o Excellent written and verbal communication skills, including people skills, such as mature emotional intelligence to be used during interactions with Subject Matter Experts (SME’s)
o Good organization and multi-tasking skills, with proven level of organization when completing redundant work. This includes data mining and input for approximately 90 assay systems.
o Must be willing to relocate to the Raleigh / Durham, NC area
o Must be flexible regarding business travel
o Qualified candidates must be legally authorized to be employed in the US

BioStat Solutions, Inc. is a voluntary equal opportunity employer

Salary Range:

Benefits: Benefits: BSSI offers a comprehensive package that includes Health Insurance coverage (Medical, Dental, Vision, prescription drugs). Health Savings Account (HSA) for qualified high deductible health plans, Basic Life Insurance, Long and Short Term Disability Insurance at no charge to the employee, 401k after eligibility period, Flexible work hours, etc..


Application Information: Please e-mail your resume / CV with recruiting source to

Contact Email:

Application Deadline: