Senior/Principal Statistical Programmer | Pharma | Fully Remote | Full-time
We are partnered with a top tier CRO who are currently seeking a highly skilled and motivated Principal Statistical Programmer with expertise in pharmacokinetics and pharmacodynamics to join their dynamic FSP team.
In this role, you will design, execute, and analyze clinical trials to support the development of promising drug candidates, collaborating with cross-functional teams of scientists, clinical researchers, and biostatisticians.
Responsibilities:
- Conduct comprehensive PK/PD data analysis using appropriate statistical methodologies to support clinical trial designs and decision-making.
- Develop robust and efficient statistical programming solutions for analyzing PK/PD data, adhering to industry best practices and regulatory standards.
- Provide valuable input during protocol development, ensuring proper incorporation of PK/PD endpoints and statistical methodologies.
- Ensure timely and accurate delivery of PK/PD data analysis for ongoing clinical trials, supporting data interpretation and presentation.
- Contribute to regulatory submissions by preparing and validating PK/PD datasets, analysis outputs, and documentation in compliance with relevant guidelines.
- Stay updated on latest PK/PD methodologies, statistical programming techniques, and industry best practices to enhance drug development strategies.
- Drive continuous improvement in statistical programming processes and contribute to the development of standard operating procedures (SOPs) for streamlined PK/PD data analysis.
Requirements:
- Master's or Ph.D. in Biostatistics, Statistics, or a related field with emphasis on PK/PD.
- Substantial experience in statistical programming using SAS, R, or other relevant languages within pharmaceutical or biotech industry.
- Experience in phase I studies creating ADPC, NONMEM (POPPK) datasets
- Proven expertise in PK/PD data analysis and interpretation, including modeling and simulation.
- Solid understanding of clinical trial designs, protocols, and regulatory requirements related to PK/PD endpoints.
- Familiarity with industry standards such as CDISC data structures and data submission guidelines is preferred.
- Strong analytical, problem-solving, and communication skills, with the ability to work effectively in cross-functional teams.
What do you get in return?
- Salary of up to $165,000 at Principal level
- Comprehensive suite of benefits
- This position offers an exciting opportunity to work remotely with a leading pharmaceutical/biotech company, contributing to groundbreaking drug development and making a significant impact on medical advancements and patient care.
Apply now with your resume to avoid missing out on this opportunity!
INDWOB
Job Type: Full-time
Pay: $130,836.42 - $165,889.02 per year
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Health insurance
- Life insurance
- Paid time off
- Vision insurance
Schedule:
Work Location: Remote