This role involves leading and supporting study teams for Analysis & Reporting of Clinical trial data through extensive programming in SAS/Equivalent software, development and validating generalized macros, and to lead the team of Statistical Programmers (In team management role) to deliver quality outputs in stipulated timeframe.
Be responsible for overall quality of assigned TA/Portfolio/Segment through expert review and feedback mechanism to delivery teams. Develop standards and work in cohesion with internal/client functional leads to derive complex programs & algorithms.
Technical Responsibilities :
Accountable for delivery of all outputs within the specified study time frame / milestones
Programming in SAS for analyzing data and producing Efficacy and/or Safety Tables, Listings and Figures in specified formats as per specifications and in accordance with Statistical Analysis Plan (SAP).
Creation and review of programming specifications
Programming in SAS for creation of derived data sets/ADaM as per the specification document
To assist management team in providing status and metrics on deliverables, resource utilization, productivity and quality of deliverable
Coordinate and communicate effectively with primary contacts at Client teams to ensure satisfactory progress of project work and timely resolution of issues
Demonstrate and promote Company global value system across all interactions
Cross functional Proactively work with Statistics, data management, Medical Writing and other functions as requiired to address data issues as identified during execution
Project management - Prompt study teams for potential slippages
Accountable for all deliverables (studies) on assigned Therapeutic Area/engagement, namely:
Responsible for quality of delieravble for assigned portfolio/TA/Group through expert level review/QC
Contribute to development of TA/portolfio levels processes, guidelines as required.
Participate in task forces, initiatives etc.
Maintain current knowledge of statistical programming practices and developments in the industry
Compliance Responsible for ensure & mentoring teams to follows relevant SoPs / guidelines for the assigned TA/Portfolio/Segment
Improvement in productivity and identify process improvement areas
Operations Management Responsibilities (as applicable):
Accountable for high quality deliverables as per agreed timelines across the portfolio and ensure high level of customer satisfaction
Optimal deployment & utilization of resources
To lead engagement level activities related to Operations, People and Client management.
Contribution to business development activities RFP, bid defense, operations setup
Risk Management to maintain business continuity
Ensure audit readiness
Plan and Manage timelines for assigned projects for self and team. Be responsible for day to day progress of work.
Responsible for performance management of team through goal setting and periodic reviews.
Identify development needs and ensure training fulfillment for the team Ensure completeness of individual training records/ log and update their training plan as per role requirement/s
Mentor, Coach & act as SME for team members in resolving any technical and operational issues
To train the team members
Ensure teams compliance to organizational policies and procedures
Process Capture and analyze study team metrics
Manage employee retention
Contribute to Recruitment activities as required
Graduate in Mathematics/Statistics/Applied Statistics/Computer Science/Life Sciences
Minimum Work Experience Required : 10 year of statistical programming in clinical/pharma domain of which minimum 2 years in management.
Minimum 2 years of Sr. Statistical Programmer experience internally or equivalent from external organization.
Strong programming and analytical skills using SAS software
Good knowledge and understanding of CDISC SDTM , ADaM and Define.xml standards
Strong knowledge of regulatory guidance documents such as ICH-E3 and ICH-E9
Strong understanding of clinical trials, fundamentals of clinical research, GCP.
Strong communication (verbal and written) & interpersonal skills. Ability to work across cross functional teams.
Good team player, self-disciplined & self-motivated with ability to learn faster.