Biostatistician

DataTEK, Inc. is a professionally managed clinical research and drug development services firm supporting pharmaceutical and biotechnology companies across the clinical development lifecycle. We deliver scalable, compliant solutions for Phase I–IV programs across multiple therapeutic areas, including Oncology, Diabetes, Alzheimer’s Disease, Arthritis, Vaccines, Infectious Diseases, Immunology, Neuroscience, and Rare Diseases.

Our core services include Drug Development Consulting, Functional Service Provider (FSP) and project-based outsourcing, staff augmentation, and direct placement services. Trusted by many of the top 50 pharmaceutical companies in the U.S. and globally, DataTEK partners with sponsors to deliver high-quality, cost-effective solutions that accelerate development timelines and reduce execution risk.

Title: Biostatistician

Salary: Depend On Experience

Location: Remote

Job Description:

Participate in Clinical trial Study Team meetings for assigned clinical trial studies; Responsible within the Clinical Study Team for the quality, accuracy and timely completion of assigned tasks; Work on analysis of clinical trials; Analyze and interpret data from individual clinical trials; Perform clinical trial analyses by pooling data from several clinical trial studies; Assist in the writing of comprehensive clinical trial reports and creative table, listing and figure shells; Prepare project summaries for weekly/monthly status meetings; Maintain state of the art statistical applications in clinical trial research; Responsible for data processing for accurate relocation, formatting, generating and transmitting required data; Prepare statistical contribution to Integrated Study Report.

Job Responsibilities:

• Independently support multiple clinical trial studies.
• Assist in the development of Statistical Analysis Plans (SAPs) under the guidance of the Principal Biostatistician.
• Contribute to the development and maintenance of statistical methods, procedures, and documentation in accordance with client requirements and internal SOPs.
• Support Senior Statisticians in the development of Tables, Listings, and Figures (TLF) shells.
• Provide SAS and R programming support for clinical trial data analysis, reporting, and regulatory submissions.
• Develop and execute statistical analyses of clinical trial data under the general guidance of Senior Statisticians.
• Validate SAS programs that generate tables, figures, and analysis datasets summarizing clinical trial results.
• Demonstrate strong SAS programming proficiency, including the effective use of procedures and macros.
• Communicate in a timely and effective manner with programming leads, Senior Biostatisticians, medical teams, and clinical technical writers.
• Perform data manipulation and statistical analyses using SAS language, procedures, and macros in compliance with FDA and ICH-GCP standards.

Education and Experience:

• MS/PhD degree S.T.E.M majors, but prefer in statistics, biostatistics, applied statistics, mathematics, computer science.
• Minimum one year experience including academical experience required or equivalent training

Knowledge, Skills and Abilities:

• Strong SAS programming skills and understand R is plus
• Strong knowledge of statistical principles and strong statistical skills
• Excellent written and verbal communications skills
• Good organizational skills with the ability to adapt and adjust to changing priorities
• Positive attitude and the ability to work well with others

Benefit:

• Holiday and Vacation pay
• Medical, Dental, Vision and Life insurance
• 401K Retirement plan
• Sponsor H-1B and GC, but prefer permanent resident and US citizenship

Salary:

• DataTEK offers a competitive salary and benefits package. The pay will be commensurate with the experience, skills, and qualifications that the candidate brings to the position.

Job Type: Full-time

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Referral program
• Retirement plan
• Vision insurance

Work Location: Remote