Biostatistician

Full-time

remote from anywhere in India

Overview

The Biostatistician is responsible for applying knowledge of statistics to prepare analysis plans and write detailed specifications for analysis files, tables, listings and figures in accordance with Atorus and/or sponsor standard operating procedures (SOPs), Good Clinical Practice (GCP), ICH Guidelines and sponsor requirements. Additional responsibilities include interpreting analyses, writing, statistical sections of study reports and providing training, guidance and mentorship to lower level and new staff.

Responsibilities

• Independently develop SAS and/or R programs to generate listings, tables and figures as outlined by a statistical analysis plan
• Perform QC of TLFs, CDISC and other analysis data sets
• Prepare specifications for CDISC and other analysis data sets
• Prepare draft statistical analysis plans under supervision
• Develop and maintain overall awareness in the field of biostatistics by reading related literature, attending training classes, professional meetings, statistical conferences etc.
• Keep detailed records of time spent on each project to allow accurate billing
• Respect and maintain the confidentiality of the processed material and ensure that any regulations concerning security or confidentiality (such as the safeguarding of passwords) are complied with
• Review and provide feedback on Data Management documents
• Ensure work completed is completed is on time at the correct level of quality
• Build strong relationships with Data management to provide proactive support.
• Participate in efforts for efficiency and productivity in the department
• Perform other work-related duties as assigned
• Attend project team and other company meetings, as required
• Participate in corporate initiatives and actions that ensure the continued success of the company

Qualifications And Requirements

• Master's Degree Biostatistics or Ph.D. Biostatistics
• 1-3 years of prior relevant experience, or equivalent combination of education, training and experience.
• 1-3 years working knowledge of SAS and/or R programming languages (combined)
• Solid understanding \& implementation of CDISC requirement for regulatory submissions.
• Knowledge of ADaM specifications generation and review of datasets.
• Intermediate level knowledge of principles, theories, and concepts of a job area, typically obtained through advanced education combined with experience.
• Excellent written and oral communication skills including grammatical/technical writing skills.
• Excellent attention and accuracy with details.
• In-depth knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines Familiarity with moderately complex statistical methods that apply to applicable clinical trials.

Preferred Skills

• Energized self-starter
• Excellent organizational skills
• Excellent communication skills, verbal and written
• Exceptional attention to detail
• Strong interpersonal skills work within a cross-functional team
• Excellent problem-solving skills
• Effective decision maker – able to exercise good judgment and take appropriate action independently
• Flexible, team player
• Proven ability to organize and effectively prioritize workload and deliverables