Education and experience:

• MSc or PhD in Biostatistics/Statistics, and having 15+ or more years of relevant experience in the CROs and/or Bio-tech/Pharma/Biopharmaceuticals environment

& responsibilities

1. Accountable for leading Biostatistics and Programming activities for the company and delivering statistical projects with acceptable Quality standards and within defined timeline & budget
2. Managing a team of statisticians and programmers and ensuring timely and quality deliverables
3. Biostatistician input into the protocol such as study design, sample size calculations and patient randomization schemes and statistical aspects of case report form design
4. Preparation of statistical analysis plans including the definition of derived data, and the design of statistical tables, figures, and data listings for clinical reports
5. Write and Review SDTM and ADaM Specifications and Perform Production and/or Validation Programming of SDTM, ADaM and TLFs.
6. Statistical analysis, Interpretation of data and reporting of results
7. Writing of the statistical methods sections of integrated study reports. Reviews draft integrated study reports.
8. Supports responses to regulatory questions on the design of the study, study endpoints, TLFs, CDISC and statistical inference
9. Participates in presentations at sponsor, DSMB, investigator meetings etc.
10. Ongoing coaching and mentorship of team members.