1. Responsible for protocol development including study design, sample
size calculation, randomization, and statistical analysis plan for
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 is accurate.
7. Mentor statistical programmers on an understanding of statistical design,
and the implementation of statistical models.
8. Ensure all activities are 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.
1. MS or Ph.D. in Statistics, Biostatistics, or related field. Ph.D. 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 with 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, and attention to detail.
7. Initiative, problem-solving, and taking extra responsibility.
8. Familiar with SAS Base, SAS/Macros, SAS/Graph, SAS/Stat, and
9. Familiar with CDISC CDASH/SDTM/ADaM standards.
Please apply using the below function and send your CV/Resume directly. Please mention that you saw this JD on the SAPA website.