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Pharmaceutical
The Biostatistician II independently programs and quality controls datasets and statistical outputs, mentors junior staff, and interacts with clients on projects.
Top Skills:
SAS
Pharmaceutical
The Senior Biostatistician coordinates project teams, interacts with clients on statistical issues, performs quality control of data, and applies advanced statistical methods to clinical trials. They also support business development through study design input, budget proposals, and client meetings.
Top Skills:
SAS
Pharmaceutical
The Biostatistician II role involves statistical analysis and the production of datasets in clinical trials, coordinating projects and mentoring junior staff.
Top Skills:
SAS
Job Description
- Providing statistical inputs for outsourced and in-source studies conducting in clinical development function
- Evaluating protocol in terms of study rationale, study objectives, study design, sample size calculation, statistical analysis of primary and secondary endpoints. Developing randomization specifications. Develop and review of Statistical analysis plans and mock shells.
Review and inputs in eCRF desigining - Provide regularly review and statistical inputs to ensure the integrity of the trial, for example, data collection and cleaning, participant withdrawal, and protocol violation.
Review and inputs in statistical programming activities. Review and ensure dry run activties to finalzie the mock TFL and fix teh data related issues.
Provide support in preparing data presentations for Data monitoring or Data safety monitoring.
Participate in data review meetings and leading blinded data review meetings to finalize the analysis populations
Performining/review of statistical analysis of clinical trail data.
Review and finalizing TFL
Review and providining inputs in clinical study report - Generation and review of pharmacokinetic data
Mandatory Skills
-Knowledge of statistical techniques and methodologies used in all phases of clinical studies knowledge of statistical programming and reporting process. Good knowledge of SOPs/Guidelines, ICH-GCP, and any other applicable local and international regulations such as 21 CFR Part 11 Knowledge of R programming Knowledge of Pharmacokinetics and WinNonlin
Dr. Reddy’s Laboratories Hyderabad, Telangana, IND Office
Hyderabad, Telangana, India
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