Manager, Statistical Programming – Line Management, SDTM Datasets, ADaM Datasets, TLFs

This is a fully remote position, open to applicants in India.

📋 Description

• Lead a team of Statistical Programmers

• Supervise project quality, budgets, timelines, and resource allocation

• Coordinate statistical programming tasks across clinical development initiatives

• Manage the creation and evaluation of SDTM datasets, ADaM datasets, Tables, Listings, and Figures (TLFs)

• Offer feedback, coaching, mentoring, and developmental assistance to team members

• Engage in performance management and evaluation of new team members

• Establish best practices, controlled documents, templates, and reusable work products

• Keep updated with industry standards and best practices

• Identify departmental challenges and collaborate with senior leadership for solutions

• Oversee a portfolio of studies ensuring timely delivery, budget adherence, and client satisfaction

• Serve as a senior reviewer and support Statistical Programming functions

• Lead or assist in the development of complex or high-priority client deliverables

• Represent Statistical Programming in front of internal leadership and external entities, including audits, bid defenses, and conferences

• Assist the Director of Biostatistics with corporate objectives, department growth, industry trends, resource forecasting, planning, metrics, and KPIs

• Head special projects aimed at enhancing departmental efficiency, profitability, and operational excellence

• Set team goals and expectations and aid in recruitment strategies

• Manage financials for projects overseen by direct reports

• Plan and coordinate statistical programming for regulatory submission integration tasks

• Consult with internal teams on statistical programming for clinical trials across various therapeutic areas

⛳️ Requirements

• Bachelor’s degree or higher in mathematics, statistics, biostatistics, computer science, or a related field

• Over 10 years of experience in Statistical Programming

• Proficiency in SAS and R

• Experience in a CRO environment is preferred

• Line management experience is essential

• Experience in creating and reviewing SDTM datasets

• Experience in creating and reviewing ADaM datasets

• Familiarity with Tables, Listings, and Figures (TLFs)

• Understanding of clinical development projects and statistical programming for clinical trials

• Awareness of industry standards and best practices

🏝️ Benefits

• Remote work options

• Emphasis on work-life balance

• Opportunities for career advancement

• Collaborative international team environment

• Supportive workplace culture

• Chance to contribute to impactful clinical research

• Access to coaching, mentoring, and development support