Alpha MD Pvt Ltd
Location
Mumbai | India
Job description
Job Description:
- Should be responsible for all statistical tasks on the assigned clinical trials: clinical trial design and planning, analysis plan, reporting activities including exploratory analyses, and additional analysis to support publications. - Should provide statistical consultation to clinical team and support decision-making process by providing adequate information. - Should work with project team to decide on appropriate study design and statistical methodology for routine designs. - Should assists in the development of randomization schedule, sample size and power calculations. - Should ensure timeliness and adequate quality of all Biostatistics and Statistical Reporting (B&SR) deliverables for the assigned trials. - Should analyze and interpret data from individual trials. Perform meta-analyses by pooling data from several studies. - Should be able to write and review Statistical Analysis Plans (SAPs) based on the protocol, including development of well-presented mock-up displays for tables, listings, and figures in collaboration with the sponsor. - Should participate in project teams as Biostatistics representative, interfacing as necessary with other departmental project team representatives. - Should follow processes and adhere to project-specific standards as well as Health Authority requirements (SOPs, Master Analysis Plan, GCP, and regulatory guidelines). - Should participate in or lead non-clinical project activities (a statistical method for identifying trends) as needed. - Should establish and maintain sound working relationships and effective communication within the organization. - Should meet established KPIs. Timely and high-quality completion of Biometrics deliverables according to established objectives. Experience : Minimum 3 years Qualification: - A master's degree in statistics or an equivalent relevant degree. - At least three (3) years as a biostatistician. - Knowledge and expertise in Statistics and statistical software packages (e.g., R, Mini tab)- Working knowledge of Good Clinical Practices, Good Manufacturing Practices, Clinical research, and clinical trials process and related regulatory requirements and terminology. - Good organizational and interpersonal skills and the ability to multi-task. - Good communication skills and the ability to speak with clients and in meetings. - Ability to train juniors and work in a team. CTC : Negotiable Location : Mumbai Keywords : Clinical trials, SASJob tags
Salary