Senior Biostatistical Programmer
1 day ago
**Company Overview:** Tata Consultancy Services Limited is a global leader in IT services, consulting and business solutions with a strong presence in India.
We are seeking a highly skilled R Biostatistical Programmer to join our dynamic team in India. This role will play a crucial part in supporting clinical trials and research studies through rigorous data analysis and statistical reporting.
Responsibilities:
- Develop and maintain statistical programming code in R for clinical trials and research studies.
- Generate and validate statistical outputs including tables, listings, and figures for clinical study reports.
- Collaborate with biostatisticians and data managers to ensure accurate and timely delivery of data analyses.
- Participate in the preparation of statistical analysis plans and contribute to protocol development.
- Evaluate compliance with regulatory requirements and internal standard operating procedures (SOPs).
- Perform quality control checks on statistical outputs and programming code.
- Document programming processes and maintain effective communication with team members.
Qualifications:
- A minimum of 2-8 years of experience in statistical programming, preferably in the pharmaceutical or biotechnology industry.
- Proficiency in R programming language and its statistical packages.
- A strong understanding of clinical trial methodologies and biostatistical concepts.
- Experience with data manipulation and analysis in R, including data wrangling with packages such as dplyr and tidyr.
- Familiarity with regulatory guidelines (e.g., ICH, FDA) related to statistical programming and clinical trials.
- Excellent problem-solving skills and attention to detail.
- Effective communication skills, both written and verbal, to convey complex statistical information clearly.
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