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Senior Associate, Statistical Programming

Remote:

Full Remote

Contract:

Full time

Experience:

Mid-level (2-5 years)

Work from:

India

Offer summary

Qualifications:

Bachelor’s Degree in relevant field, 2 years' experience in Biostatistics or Statistical Programming, Experience in leading programming teams preferred, Strong knowledge of drug development and clinical research, Fluent English (oral and written).

Key responsabilities:

Create quality outputs meeting project requirements
Maintain organized project documentation and programs
Develop regulatory submission documentation and datasets
Ensure on-time delivery of programming tasks
Attend required trainings on regulations and GCP

Biorasi

201 - 500 Employees

See more Biorasi offers

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.

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:

Create outputs that meet quality standards and project requirements.
Maintain well organized, complete up-to-date project documentation, and verification/quality control documents and programs ensuring inspection readiness.
Read and understand the Study documents (Protocol, eCRF, Dataset specifications, SAP, Mock shells etc.) and provide feedback if any.
Contribute to project-specific objectives and team deliverables.
Responsible for on-time delivery across concurrent programming deliverables.
Develop annotated CRFs and regulatory submission documentation including Define.xml and data reviewer’s guides.
Learn to 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 datasets (SDTM/ADaM) and Tables, Listings, and Figures (TLFs) using the aCRF, programming specifications, and SAP.
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:

Bachelor’s Degree in Mathematics/Statistics, Life Sciences, Computer Science, or related field.
Fluent English (oral and written)
At least 2 years’ experience 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.