Biostatistician

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