Statistical Programming Lead

4 days ago

Hyderabad Secunderabad Telangana Pune Chennai, India beBeeStatisticalProgrammingLead Full time ₹ 9,00,000 - ₹ 12,00,000

Our organization seeks a highly experienced Statistical Programming Lead to develop custom programming code, manage multiple projects, and act as a technical leader for a team of statistical programmers.

Key Responsibilities
  • We use SAS or other software to generate summary tables, data listings, graphs, and derived datasets.
  • The outputs meet quality standards and project requirements.
  • We perform validation programming and collaborate with project teams to resolve discrepancies.
  • The programmer manages scheduling and time constraints across multiple projects, setting goals and adapting to changes in priorities.
  • The person develops specifications for datasets and outputs of any complexity.
  • As the lead statistical programmer, we direct the activities of other programming personnel and monitor their progress.
  • We review project documentation, such as the Statistical Analysis Plan, mock shells, and programming specifications, providing feedback to reduce inefficiencies.
  • The programmer participates in sponsor meetings, kickoff meetings, and bid defense meetings as the statistical programming representative.
  • They contribute to the mentoring of programming personnel by developing training courses and providing guidance to new associates.
  • As a technical expert resource, we serve for complex programming questions, with a good working knowledge of clinical drug development, industry standards, and electronic submission requirements.
Required Skills and Qualifications
  • The programmer should have extensive experience in SAS or other required software, preferably in a clinical trial environment.
  • A strong understanding of CDISC Standards for regulatory agency requirements is also essential.
  • Experience with submissions to a regulatory agency is preferred.
  • The ability to mentor others in clinical trial processes and CDISC Standards is an added advantage.
  • Excellent written and verbal communication skills are necessary.
  • The programmer must be able to manage concurrent programming deliverables and negotiate timelines effectively.
  • Familiarity with applicable SOPs, WIs, and relevant regulatory guidelines (e.g., ICH) is required.
Benefits

Our organization offers a dynamic work environment where you can leverage your expertise to drive success. As a member of our team, you will enjoy opportunities for growth, professional development, and collaboration with experienced professionals in the field.

Others

To excel in this role, you must possess a strong passion for statistical programming and a commitment to delivering high-quality results. If you are a motivated and detail-oriented individual with excellent communication skills, we encourage you to apply.

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