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Job Function:

Data Analytics & Computational Sciences:

Job Sub Function:

Biostatistics

Job Category:

Scientific/Technology

All Job Posting Locations:

Bangalore, Karnataka, India, Mumbai, India, PENJERLA, Telangana, India

Job Description: Principal I Clinical Programming Lead (SDTM Programming)Position Summary:

The Principal Programming Lead is a highly skilled Programmer with expert knowledge of programming languages, tools, and complex data structures, industry standards. The position requires proven technical and analytic abilities and strong capabilities in leading activities and programming teams in accordance with departmental processes and procedures.
As a highly experienced Principal Programming Lead, they apply expert technical, scientific, problem-solving skills providing innovative and forward-thinking solutions to ensure operational efficiency across assigned projects providing training, coaching, mentoring to other programmers.

The Principal Programming Lead position is accountable for the planning, oversight, and delivery of programming activities in support of one or more clinical projects, compounds, or submissions of high complexity and criticality.

In this role, the Principal Programming Lead is responsible for making decisions and recommendations that impact the efficiency, timeliness, and quality of deliverables with a high degree of autonomy and provide leadership, direction and technical and project specific guidance to programming teams. In addition, this position may lead and contribute expert knowledge and technical skills to assigned delivery unit, departmental innovation, and process improvement projects.

Principal Responsibilities:

• Designs and develops efficient programs and technical solutions in support of highly complex/critical clinical research analysis and reporting activities, including urgent/on-demand analysis requests.
• Provides technical and project specific guidance to programming team members to ensure high quality and on-time deliverables in compliance with departmental processes.
• Coordinates and oversees programming team activities and may provide matrix leadership to one or more programming teams as needed. Shares knowledge and provides guidance and coaching to programmers in developing advanced technical and analytical abilities.
• Performs comprehensive review of, and provides input into, project requirements and
  documentation.
• Collaborates effectively with programming and cross-functional team members and counterparts to achieve project goals and independently manages escalations.
• As applicable, oversees programming activities outsourced to third party vendors adopting appropriate processes and best practices to ensure their performance meets the agreed upon
  scope, timelines, and quality.
• Responsible for adoption of new processes & technology on assigned projects/programs in collaboration with departmental technical groups and programming portfolio leads
• Oversees the design, development, validation, management, and maintenance of clinical databases according to established standards.
• Responsible for implementation of data tabulation standards.
• Performs data cleaning by programming edit checks and data review listings and Data reporting by creating data visualizations and listings for medical monitoring and central monitoring.

Education and Experience Requirements:

Bachelor's degree (e.g., BS, BA) or equivalent professional experience is required, preferably in Computer Sciences, Mathematics, Data Science/Engineering, Public Health, or another relevant scientific field (or equivalent theoretical/technical depth). Advanced degrees preferred (e.g., Master, PhD).

Experience and Skills Required:

• Approx. 10 -12+ years of experience in Pharmaceutical, CRO or Biotech industry or related field or industry. People management experience is mandate.
• In-depth knowledge of programming practices (including tools and processes).
• Working knowledge of relevant regulatory guidelines (e.g., ICH-GCP, 21 CFR Part 11).
• Project, risk, and team management and an established track record leading teams to successful outcomes.
• Excellent planning and coordination of project delivery.
• Established track record collaborating with multi-functional teams in a matrix environment and partnering with/managing stakeholders, customers, and vendors.

Required Skills: Preferred Skills:

Advanced Analytics, Biostatistics, Clinical Data Management, Collaborating, Compliance Management, Critical Thinking, Data Privacy Standards, Good Clinical Practice (GCP), Organizing, Presentation Design, Program Management, Quality Assurance (QA), Regulatory Affairs Management, Research Documents, Standard Operating Procedure (SOP), Statistical Analysis Systems (SAS) Programming, Survey Design