- Position: – Senior /Principal Statistical Programmer
- Min 4+ years of CRO/ Pharma Industry
- Therapeutic Areas: Oncology // Immunology // IDV // EDCP
- Must have expertise of R programming
- SAS® Base, and good knowledge of SAS® graph and SAS® Macros.
- Capable of implementing more advanced statistical procedures as per specifications provided by biostatistician.
- Must have excellent knowledge of CDISC standards (SDTM and ADaM)
- Thorough understanding of relational database components and theory.
- Excellent application development skills.
- Strong understanding of clinical trial data and extremely hands on in data manipulations, analysis and reporting of analysis results.
- Good understanding of ICH E6, ICH E3, ICH E8, ICH E9 and clinical research processes.
- Minimum of 8+ years of experience in Statistical Programming in pharmaceutical or medical devices industry
- Good verbal and written communication skills.
- Ability to work on multiple projects, plan, organize and prioritize activities.
Required Knowledge, Skills and Abilities:
- Experience as technical team lead directly engaging clients and coordinating tasks within a programming team
- In-depth knowledge of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
- Knowledge of statistics, programming and/or clinical drug development process
- Advanced knowledge of Base SAS, SAS/STAT, SAS Graph and SAS Macro Language
- Should have experience with SDTM Implementation and ADaM implementation according to CDISC Standards.
- Must have expertise in SAS/BASE, SAS/MACRO, SAS/STAT, SAS/GRAPH, SAS/ACCESS, SAS/ODS, SAS/SQL.
- Good organizational, interpersonal, leadership and communication skills
- Ability to independently manage multiple tasks and projects
- Ability to delegate work to other members of the SP team
- Excellent accuracy and attention to detail
- Ability to delegate work to other members of the SP team [SPM]
- Exhibits routine and occasionally complex problem-solving skills
- Ability to lead teams and projects and capable of managing at a group level
- Recognizes when negotiating skills are needed and seeks assistance.
- Ability to establish and maintain effective working relationships with coworkers, managers and clients.
- Perform, plan co-ordinate and implement the following for complex studies: (i) the programming, testing, and documentation of statistical programs for use in creating statistical tables, figures, and listing and (ii) the programming of analysis datasets (derived datasets) and transfer files for internal and external clients and (iii) the programming quality control checks for the source data and report the data issues periodically..
- Ability to interpret project level requirements and develop programming specifications, as appropriate, for complex studies.
- Provide advanced technical expertise in conjunction with internal and external clients, and independently bring project solutions to SP teams and Statistical Programming department, for complex studies.
- Fulfill project responsibilities at the level of technical team lead for single complex studies or group of studies.
- Directly communicate with internal and client statisticians and clinical team members to ensure appropriate understanding of requirements and project timelines.
- Estimate programming scope of work, manage resource assignments, communicate project status and negotiate/re-negotiate project timelines for deliverables.
- Use and promote the use of established standards, SOP and best practices.
- Provide training and mentoring to SP team members and Statistical Programming department staff.
MINIMUM REQUIRED EDUCATION AND EXPERIENCE:
- Bachelor’s degree from reputable university preferably in science/ mathematics related fields