Biostatistician II

Location: Philippines-Clark or India-Mumbai/Pune

Duration: Long-term contract opportunity

JOB DESCRIPTION

Biostatistician II statistical analyses for clinical research studies as outlined in statistical analysis plans, including creating statistical graphics and verifying randomization codes. They prepare statistical sections of protocols, including sample size calculations, annotate shell data displays, and provide specifications for the structure, content, and algorithms of status and analysis datasets. They perform and oversee quality control (QC) of data displays with inferential statistics.

QUALIFICATIONS FOR ESSENTIAL FUNCTIONS

1. Develop, validate, and maintain SAS programs to create analysis datasets, tables, listings, and figures (TLFs) as specified in statistical analysis plans.

2. Design and verify randomization codes to support clinical trial integrity.

3. Prepare statistical sections of protocols, including sample size calculations, and annotate shell data displays.

4. Provide specifications for the structure, content, and algorithms of status and analysis datasets.

5. Perform and oversee quality control (QC) of data displays and analysis datasets to ensure accuracy and compliance with CDISC standards (SDTM, ADaM).

6. Conduct independent validation of datasets created by other programmers or statisticians.

7. Maintain project administration files, including protocols, annotated CRFs, statistical analysis plans, and programming/QC documentation.

8. Manage electronic project directories to ensure organization and accessibility of deliverables.

9. Mentor and guide junior programmers, providing training on SAS programming and clinical data standards.

EDUCATION AND EXPERIENCE REQUIRED

1. Master's degree in Statistics or equivalent combination of Education and Experience (e.g. a Bachelor’s degree and at least 3 years of industry experience as a biostatistician) required.

2. A minimum of 3 years of experience as a statistician is required for the Senior Statistician position. A minimum of 1 year of supervisory approval is required for the non-Senior

Statistician level

3. Proficient in SAS and similar clinical data analysis software.

WORK REQUIREMENTS

1. Corporate office environment, unless home-based.

2. Some travel (5%) may be required, with a potential of travel occurring over weekends.

3. Cross-functional interactions

TRAINING

• Complete Training Requirements per the current Training Requirements List.

• Manager will assign additional skills training, one-on-one, see-one / do one, or other Training as necessary to achieve qualifications and improve job performance.

To apply, please send your resume to admin@hipaas.com