Job Description

We are Growing! Let us support your career journey the Biorasi way. Innovative, Collaborative, Dynamic and Evolving. Capitalizing on your strengths while encouraging work-life balance. Biorasi is an award-winning, customer-focused, full-service clinical research organization, and we are unlike any CRO you\xe2\x80\x99ve ever heard of.

Biorasi is looking for top performers who are as passionate about clinical research as we are \xe2\x80\x93 clinical trial veterans and industry newcomers who will thrive in our fast-paced environment and help us drive new therapies to patients. Here is your chance to become a vital part of a growing global company in the expanding clinical research industry.

Start your career journey at Biorasi today with our newest opportunity- Principal, Biostatistics. This is a remote based position located anywhere in India.

Overview

• We are international: Our headquarters is in Aventura, Florida. Other locations are in Europe and in India
• Our work culture includes: teamwork, hands-on mentality, flexibility, and open communication.
• Development and work life balance: We want our employees to develop personally as well as professionally.

Job Responsibilities

• Provide input to study design for clinical trials as needed.
• Develop or perform biostatistical review of randomization schedules; Statistical Analysis Plans (SAPs); mock shells for Tables, Listings, and Figures (TLFs); draft and final TLFs; statistical sections of protocols and Clinical Study Reports (CSRs); programming specifications; clinical study databases (SDTM/ADaM); and related metadata (i.e., define.xml, data reviewer\xe2\x80\x99s guides).
• Review and approve case report forms (CRFs), study plans, and external data transfer agreements as needed.
• Provide biostatistics support to the statistical programming team and other internal study teams.
• Serve as main point of contact for biostatistics for sponsors and other external clients/vendors.
• Effectively communicate statistical concepts to non-statisticians.
• Ensure on-time delivery of outputs that meet quality standards and project requirements across multiple projects.
• Assist in updating biostatistics and statistical programming SOPs, guidance, and work instructions.
• Lead and assist others in conducting statistical activities in compliance with SOPs, relevant regulatory requirements, and company standards.
• Maintain well organized, complete up-to-date project documentation, and verification/quality control documents and programs ensuring inspection readiness.
• Support internal/external audit processes.
• Maintain a high level of professionalism, performance, productivity and quality.
• Undergo Regulatory trainings, ICH GCP and 21 CFR Part 11 trainings.
• Other biostatistics duties and responsibilities as assigned.

Ideal Background

• Master\xe2\x80\x99s Degree or PhD in Statistics or Biostatistics
• Fluent English (oral and written).
• Available to maintain a work schedule that overlaps with the US-based team from 8:30a - 12p EST.
• At least 5 years\xe2\x80\x99 experience in Biostatistics within the pharmaceutical industry or related field.
• Strong experience in writing Statistical Analysis Plans (SAPs) as well as statistical sections of protocols and Clinical Study Reports (CSRs).
• Demonstrated experience planning and coordinating statistical activities.
• Experienced with clinical trial design, generating randomization schedules, sample size/power analyses, and statistical analyses.
• Experience in advanced statistical methodologies (e.g., multiple imputation, mixed models, GEE models, etc.)
• PK analysis experience is a plus.
• Pay close attention in detail, timeliness and quality.
• Strong problem-solving and leadership skills with the ability to contribute creative and practical solutions to complex problems.
• Solid understanding of statistical theory and its applications to the pharmaceutical industry or other clinical research field.
• Excellent team working characteristics, capable of working in cross-functional teams.
• Significant knowledge of drug development and clinical research.
• Good knowledge and understanding of ICH GCP and worldwide applicable regulatory requirements.
• Must demonstrate the ability to operate in a fast-paced environment and respond with agility when priorities change.
• Excellent time management and planning skills.
• Excellent verbal, written communication, and presentation skills.

If you have the experience required and want to join an energetic, creative, and collaborative team, please apply directly to our website at https://biorasi.com.

We strive to provide our employees and their families with benefits that are thoughtfully designed to enhance your health and well-being. Our employees enjoy summer half-day Fridays, paid time off, paid holidays, extensive country specific benefits, employee bonus programs, career growth, training and development.

Biorasi is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. Biorasi is also committed to compliance with all fair employment practices regarding citizenship and immigration status.

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