Lead, Statistical Programming

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

Biorasi is looking for top performers who are as passionate about clinical research as we are 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

Your Role

Ensure that outputs meet quality standards and project requirements

Guide and ensure well organized, complete up-to-date project documentation, and verification/quality control documents and programs are kept ensuring inspection readiness

Read and understand the Study documents (Protocol, eCRF, Dataset specifications, SAP, Mock shells etc,) and provide feedback if any

Develop and maintain standard programs, macros, templates, and libraries for statistical programming activities

Contribute to project-specific objectives and team deliverables

Responsible for on-time delivery across concurrent programming deliverables

Resolves complex statistical programming obstacles and provides guidance to teams

Develop annotated CRFs and regulatory submission documentation including Define

xml and data reviewers guides

Develop programming specifications as per the client requirements and compliant to the CDISC standards and to develop programming plan for statistical outputs (datasets, tables, listings, figures, etc,) supporting clinical study reports, regulatory submissions, and publications

Develop/validate CDISC compliant complex datasets (SDTM/ADaM) and Tables, Listings, and Figures (TLFs) using the aCRF, programming specifications, and SAP

Serve as a back-up to primary contact for sponsors, vendors, and the project team for study related programming activities

Review/approve electronic Case Report Forms (eCRFs) as required

Drive/enable limited number of small teams of internal/consultant programmers to make progress on programming activities/deliverables

Maintain a high level of professionalism, performance, productivity, and quality

Undergo Regulatory trainings, ICH GCP and 21 CFR Part 11 trainings

Other statistical programming duties and responsibilities as assigned

Your Profile

Bachelors Degree in Mathematics/Statistics, Life Sciences, Computer Science or related field or equivalent experience

Fluent English (oral and written)

At least 3 yearsexperience in Biostatistics or Statistical Programming within the pharmaceutical industry or related field

Experience in planning and coordinating programming activities and leading programming teams is strongly preferred

Ability to multitask and prioritize work

Pay close attention in detail, timeliness, and quality

Strong problem-solving and leadership skills with the ability to contribute creative and practical solutions to problems

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

Excellent time management and planning skills

Excellent communication skills, both written and verbal

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 or email us at careers@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 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