Junior Manager – Biostatistics
Location: Semicon Park, Bangalore, India
Division: Discovery Services
Department: Biostatistics & SAS Programming
Employment Type: Full-Time
Company Overview:
Syngene International is an innovation-led contract research, development, and manufacturing organization (CRDMO) providing integrated scientific services from early discovery through commercial supply. With safety, integrity, and excellence at the core, Syngene fosters a culture that emphasizes scientific rigor, operational discipline, and compliance with global standards.
Role Overview:
The Junior Manager – Biostatistics will perform advanced biostatistical activities in support of clinical studies (Phase I-IV), ensuring statistical integrity, analysis quality, and adherence to protocols and regulatory guidelines. This role involves mentoring junior statisticians, supporting clinical operations, and providing expert statistical consultation.
Key Responsibilities:
Review study protocols and contribute to Statistical Analysis Plans (SAP) and Randomization Allocation Plans (RAP).
Conduct sample size calculations and provide statistical consultation.
Prepare and review randomization lists, tables, listings, graphs, and statistical reports.
Perform statistical analysis in alignment with SAP and protocol requirements.
Review SDTM and ADaM datasets for accuracy and compliance.
Support blinding and unblinding documentation processes.
Develop, review, and maintain Standard Operating Procedures (SOPs) in biostatistics.
Mentor and guide associate biostatisticians and junior programmers.
Handle statistical queries from clients and provide technical guidance to cross-functional teams.
Contribute to team objectives, performance appraisals, and continuous improvement initiatives.
Essential Qualifications & Experience:
M.Sc. or Ph.D. in Statistics or equivalent.
Expertise in SAS programming and statistical software.
Hands-on experience in clinical trials, including Phase I-IV studies and pharmacokinetics studies.
Strong analytical, problem-solving, and documentation skills.
Excellent communication skills for client interactions and cross-functional collaboration.
Core Values & Leadership Expectations:
Uphold Excellence, Integrity, and Professionalism in all work.
Promote a culture of Environment, Health, Safety, and Sustainability (EHSS).
Provide leadership in people management, career planning, and talent retention (for leadership hires).
Equal Opportunity Employer:
Syngene provides equal employment opportunities to all qualified candidates and ensures reasonable accommodations for individuals with disabilities.
Learn More: Syngene Careers – Discovery Services
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