Job Title: Statistical Programmer II
Location: India
Company: Novotech
Job Overview:
As a Statistical Programmer II at Novotech, you will contribute to the success of clinical studies by managing statistical programming tasks, generating analysis datasets, and ensuring compliance with industry standards. You will work closely with biostatisticians, project teams, and clients, driving efficiency in data analysis and submission processes.
Key Responsibilities:
Clinical Projects:
Review clinical study protocols and Statistical Analysis Plans (SAPs).
Estimate programming time and develop risk mitigation plans.
Design and maintain SDTM, ADaM, or analysis dataset specifications.
Develop and review programming outputs, including tables, figures, and listings (TFLs).
Ensure adherence to data standards and maintain accurate documentation.
Represent Novotech in client meetings.
Clinical Product Development:
Conduct gap analyses for clinical study databases.
Develop regulatory submission packages, including SDTM, ADaM datasets, Define.xml, and reviewers' guides.
Mentorship and Development:
Mentor junior staff and assist with onboarding.
Contribute to automating statistical programming tasks and developing SAS macros.
Compliance and Collaboration:
Ensure compliance with regulatory guidelines and company policies.
Advise on CRF libraries and data dictionaries based on CDASH and SDTM standards.
Participate in internal meetings and external industry forums.
Qualifications & Experience:
Education: Bachelor’s degree in Life Sciences, Computer Science, Mathematics, Statistics, or a related quantitative field.
Experience: Minimum 5 years in pharmaceutical/CRO industries with SAS programming experience in clinical studies.
Proven expertise in leading clinical study or project teams.
Technical Skills:
Exceptional SAS programming skills.
Knowledge of CDISC standards (SDTM and ADaM).
Familiarity with regulatory submission requirements.
Why Join Novotech?
Competitive pay and benefits, including flexible working options and wellness programs.
Inclusive workplace culture, supporting diversity and equal opportunities.
Opportunities for career development and mentorship.
ISO-certified for IT security and quality standards.
About Novotech:
Novotech is a leading Asia-Pacific biotech specialist CRO, offering clinical development services across all trial phases. With 3,700+ clinical projects and 2,750+ team members across 11 geographies, Novotech is at the forefront of biotech clinical trials.
For more information, visit Novotech.
Apply Today
Be part of a diverse and innovative team making a difference in clinical research and biotech.
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