Clinical Biostatistician

Location: Bangalore or Hyderabad, India (On-site)

Hiring Company Name: ACHNET Demo

Hiring Company Location: San Ramon, CA, USA

Job Type: Full-time

Experience Level: Mid-Level (Minimum 5 years)

Job Overview

We are seeking a highly motivated and experienced Clinical Biostatistician to join our team. In this role, you will be responsible for providing statistical expertise in the design, analysis, and reporting of clinical trials in the field of Oncology within the pharmaceutical industry. You will collaborate with cross-functional teams to ensure the integrity and validity of clinical trial data and contribute to the development of innovative therapies.

Key Responsibilities

1. Develop statistical analysis plans (SAPs) and contribute to study protocols.
2. Perform statistical analyses of clinical trial data using appropriate statistical methodologies.
3. Interpret and summarize statistical results for clinical study reports (CSRs), publications, and regulatory submissions.
4. Collaborate with clinical scientists, data managers, and other team members to ensure data quality and integrity.
5. Provide statistical support for regulatory interactions and submissions.
6. Stay up-to-date with the latest statistical methodologies and regulatory guidelines.
7. Contribute to the development and improvement of statistical processes and procedures.

Educational Qualifications

1. Master's or Ph.D. degree in Biostatistics, Statistics, or a related field.

Must-Have Skills

1. Minimum of 5 years of experience in biostatistics within the pharmaceutical industry.
2. Strong knowledge of statistical methodologies for clinical trial design and analysis.
3. Proficiency in statistical programming languages such as SAS and/or R.
4. Experience in Oncology clinical trials.
5. Excellent communication and interpersonal skills.
6. Familiarity with regulatory guidelines (e.g., FDA, EMA).

Good-to-Have Skills

1. Experience with adaptive clinical trial designs.
2. Knowledge of data visualization techniques.
3. Experience with CDISC standards (e.g., SDTM, ADaM).

Pay Rate/Salary

Competitive salary commensurate with experience.

Number of Openings

1