AM/Manager/Sr Manager - Bio-Statistician

FYI: Experience bracket is from 4 years to 12 years

Job Description:

We are seeking a Biostatistician/Senior Biostatistician to join our high growth global Clinical Research Services business unit.

- The position can be based in Mumbai, India. This is a high impact role providing statistical input into Phase 1-4 clinical trial development, performing the analysis of clinical trial data, and providing statistical input into the reporting of clinical trial results.

- Experience in Statistical Analysis Plan or Statistical Analysis Report is mandatory

Your responsibilities will include:

- Providing statistical input into protocol and case report form (CRF) development in all therapeutic areas (e.g., trial design, sample size estimation, randomization, statistical methods for protocols, edit checks for clinical trial data).

- Communicating with clients regarding study protocol or statistical analysis issues.

- Writing detailed statistical analysis plans including specifications for analysis files, consistency checks, tables, and figures.

- Analyzing clinical trial data producing accurate results representing the outcome of the trial. Validates statistical output.

- Accurately interpreting statistical results and concepts.

- With the medical writer, co-authoring final integrated reports of clinical trial data by writing thorough and clear statistical methods sections and producing the statistical appendix for the final report.

- Providing input into statistical standard operating procedures (SOPs) and general standardization efforts within the department (e.g., statistical methodology standards, standard data presentations).

- Participating in interactions with regulatory agencies, as required.

- Collaborating effectively with members of clinical trial implementation teams and with Biometrics colleagues.

Desired Skills and Experience:

- You will have a B.Sc/ M.Sc. degree in Statistics or Biostatistics or Economics or Mathematics with some applied statistics training relevant to the clinical trials or health research environment or a Masters degree in Statistics or Biostatistics or a related health science field, and one to five years biostatistical experience in the clinical trials or health research environment.

Additionally, we require:

- Excellent written and oral communication skills including grammatical/technical writing skills.

- Familiarity with moderately complex statistical methods that apply to Phase I-IV clinical trials.

- SAS proficiency preferred.