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, SAS

Biostatistician - Clinical Research (3-5 yrs)