Associate Director - Clinical Research (15-25 yrs)

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

Job Location: On site (Ahmedabad)

Core Job Responsibilities:

- Overall responsible and accountable for managing, leading, and overseeing all statistical tasks on the assigned clinical studies: clinical study design/planning, statistical analysis plan, reporting activities including exploratory analyses, and additional analysis to support clinical study report and publications.

Role & 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.

People Management Skills:

- Responsible for staff selection, interview, and adequate resourcing of the statistician group for on-going projects and forecasting of resourcing needs.

- Supervise, train, and mentor statistician, and SAS team members including new recruits Team Lead, team player and seasoned professional skills:

- Excellent leadership skills

- Experience in developing both internal and external consultative relationships with senior management and executives

- Willingness to work under pressure to meet multiple and sometimes competing deadlines

- Ability to work well in a team as well as independently and take leadership roles with regard to methodological elements in projects

- Ability to communicate effectively, in non-technical terms, with project team members

- Excellent business writing, and communication presentation skills with close attention to detail

- A strong communicator (spoken and written) and problem-solving skills, and an ability to learn quickly

- Experience of Supporting the global regulatory submission and approval would be an added advantage

- Global regulatory guidance

Language skills:

- Excellent interpersonal written, and oral communication in English

Computer skills:

- Strong statistical programming skills with standard software, including SAS (Base, Stat, Graph, Macro), Phoenix WinNonlin, SPSS, nQuery, R and other statistical tools commonly used in life science industry