Biostatistician

2 months ago

Mumbai, India Alpha MD Pvt Ltd Full time

**JD of Biostatistician**

**General Information**

**Designation: BIOSTATISTICIAN**

**Status: Full-time**
- Should be responsible for all statistical tasks on the assigned clinical trials: clinical trial de-sign/ 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 analyse 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 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 (Statistical Method for identifying out of 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**:

- Master’s degree in statistics or equivalent relevant degree.
- At least three (3) years as 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, Clinical trial process and related regulatory requirements and terminology.
- Good organizational, interpersonal skills and able to multi-task.
- Good communication skills and ability to speak with clients and in meetings.
- Ability to train juniors and work in a team.

**Location: Mumbai**

**Keywords: Clinical trials, SAS, Biometrics**

**Salary**: ₹400,000.00 - ₹500,000.00 per year

**Benefits**:

- Provident Fund

Schedule:

- Monday to Friday

Application Question(s):

- What is your current CTC?
- What is your expected CTC?
- What is your notice period?

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