Job Purpose: Provides end to end statistical programming activities for study deliverables under guidance, by programming analysis datasets, listings, figures, and tables according to specifications and supporting ad hoc programming requests under supervision of statistician lead.

  1. Collaboration with team members to ensure alignment to corporate and TA standards and ensure implementation of functional best practice and lessons learned

  2. Quality review of key study deliverables:  Raw, SDTM and analysis databases, statistical reporting outputs

       - Accuracy of database structures, values and algorithms

       - Adherence to analysis and standards requirements for study databases

       - Accuracy and completeness of specifications, program validation plans and documentation from biometrics vendors

       - Make complementary note that this role could have biostatistics quality focus on key efficacy and safety endpoints, statistical interpretation and analysis going into the CSR and HLDs

   3. Collaboration with study team members in database development and study initiation activities to ensure that data collections, data coding and management meet study requirements

   4. Contribute to the preparation and quality review of regulatory submission package

   5. Programming and validation of patient data and summary reports to support ad hoc analyses or responses to regulatory queries

   6.  Ensure and maintain internal quality documentation for statistical programming deliverables as per company procedures

Knowledge, Skills & Experience

1.  Master  in Mathematical, Statistical, Computer Science or Life Science
2.  SAS programming knowledge
3.  Awareness of database set-up and report publishing requirements
4.  Awareness of technical requirements related to the role
5.  Awareness of CDASH/CDSIC and ADaM standards and industry best practices
6.  Good verbal and written communication skills
7.  Knowledgeable of the drug indications within a therapeutic area is plus, eg. Oncology
8.  1 year plus of clinical trial experience or high potential considered
9.  Ability to apply programming expertise to problems and resolve issues with quality focus
10.  Ability to work proactively and collaboratively with the project team member with ability to constructively challenge other team members and be receptive to challenge in bringing clarity and robustness to decision making
11.  Other programming languages e.g. S-PLUS, R, XML etc