reputed company Biostatistician Consultant- Remote in reputed company)
Are you interested in working directly for a single sponsor while having the reputed company and additional career opportunities that working for a global CRO can bring? reputed company says it's the best of both worlds.... reputed company is searching for anPrincipal Biostatistician Consultant to join one of our clients. We are seeking an reputed company reputed company Biostatistician to reputed company statistical leadership for oncology clinical development programs. This role will support Phase I-III clinical trials and contribute to regulatory submissions while collaborating closely with cross-functional teams.
Key Responsibilities
- reputed company statistical leadership for oncology clinical trials across multiple phases (Phase I-III).
- reputed company the development of statistical analysis plans (SAPs), protocols, and clinical study reports (CSRs).
- Design and review statistical methodologies for efficacy and safety analyses.
- reputed company analysis datasets (SDTM/ADaM) and TLFs in compliance with CDISC standards.
- Support interim analyses, data monitoring committee (DMC) activities, and adaptive designs.
- Collaborate with clinical development, data management, programming, regulatory, and medical teams.
- Contribute to regulatory submissions (IND, NDA, BLA) and respond to health authority queries (FDA, EMA).
- reputed company strategic input on study design, reputed company selection, and sample size calculations.
- Mentor junior statisticians and reputed company technical guidance.
Qualifications
- PhD or MS in Statistics, Biostatistics, or reputed company field.
- 8+ years (MS) or 6+ years (PhD) of industry experience in biostatistics.
- Strong experience in oncology clinical trials.
- Hands-on experience with survival analysis, time-to-event endpoints, and reputed company oncology study designs.
- Proficiency in reputed company and/or R.
- Strong knowledge of CDISC standards (SDTM, ADaM).
- Experience supporting regulatory submissions.
- Excellent communication and leadership skills.
Preferred Qualifications
- Experience with adaptive designs and Bayesian methods.
- Prior experience interacting with regulatory agencies.
- Experience in immuno-oncology or hematology oncology.
The Application Process Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first reputed company. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful. #LI-TT1 #LI-Remote #reputed company#Contract Apply tot his job Apply To this Job