Location : Remote (WFH)

Experience :

- Principal : 10+ years with 2 years of Management experience

- Senior : 7 - 9 Years with project management skills

Job Responsibilities :

- Act as Statistical programming lead for large global or other major programs.

- Act as SME & provide technical solutions and advice to the staff and to clients on statistical programming.

- Act as subject matter expert for large-scale complex projects, providing hands-on support for the completion of projects and solve critical technical problems.

- Work on process optimization & develop standard macros or applications to improve the efficiency, quality, and productivity of the department.

- Provide advanced technical training to internal members.

- Mentor and train junior team members.

- Ensure all statistical activities in accordance with internal and external quality standards, SOPs/WPDs, ICH-GCP and/or other international/local regulatory requirements.

- Provide support during internal & client audits.

- Learn internal and external SOPs/WPDs, ICH-GCP and/or other international/local regulatory requirements.

- Initiate and participate in the ongoing review and improvement of processes activities.

- Participates in the review of Case Report Forms (CRFs), CRF annotations, Statistical Analysis Plans, SDTM/ADAM specifications, and datasets, and TLFs.

- Strong oral and written communication skills.