Department

Statistics

Responsibilities

1. Responsible for protocol development including study design, sample size calculation, randomization, and statistical analysis plan for assigned studies.

2. Provided statistical oversight to studies and assure adequate quality and consistency with project requirements.

3. Attend (as appropriate) client meetings including, but not limited to, project kick-off meetings, resource/timelines discussions, bid defenses, blind data review meetings etc.

4. Manage activities of statisticians by appropriately coordinating assignments and reviewing work so that projects are delivered on time with high quality.

5. Review case report form and other data management documents including, but not limited to edit check specifications, data review plan, data transfer specification etc.

6. Review/validate programming deliverables including, but not limited to programming specifications, analysis datasets and tables, figures, and listings to ensure to meet the analysis requirements. Ensure the interpretation of the results are accurate.

7. Mentor statistical programmers on understanding of statistical design, and the implementation of statistical models.

8. Ensure all activities in accordance with internal and external quality standards, SOPs/WIs, ICH-GCP and/or any other applicable local and international regulations, guidelines and industry standards.

Qualification

1. MS or PhD in Statistics, Biostatistics or related field. PhD with 2-3 years of experience or MS with 4-6 years of experience in pharmaceutical or related industry experience with clinical trials.

2. Solid knowledge of statistics.

3. Compliance in SOPs/WIs, ICH-GCP and any other applicable local and international regulations, guidelines and industry standards.

4. Show commitment to and perform consistently high-quality work.

5. Excellent communication skills in both verbal and written English.

6. Timeline adherence, reliability, good efficiency, attention to details.

7. Initiative, problem solving and take extra responsibility.

8. Familiar with SAS Base, SAS/Macros, SAS/Graph, SAS/Stat and reporting process.

9. Familiar with CDISC CDASH/SDTM/ADaM standards