Manager 2, Statistical Programming

Accountabilities: The Manager 2, Statistical Programming will lead statistical programming activities across clinical studies, ensuring high-quality deliverables that support clinical development, reporting, and regulatory requirements. The role requires strong technical expertise, independent execution, and effective collaboration with global teams and stakeholders.

Lead statistical programming activities for Phase I–IV clinical studies across assigned therapeutic areas, compounds, or indications.

Plan, execute, and monitor programming deliverables to ensure timely and high-quality project outcomes.

Develop and maintain programming documentation according to established standards and processes.

Create and review CDISC-compliant SDTM mapping specifications and ADaM specifications.

Develop and oversee SAS programs for SDTM and ADaM datasets, as well as statistical reports including tables, listings, and figures.

Contribute to the creation and maintenance of standard macros, utility programs, and statistical programming standards.

Participate in CRF annotation, Statistical Analysis Plan (SAP) reviews, TLF specification development, and TLF quality reviews.

Support regulatory submission activities by managing required documentation packages and compliance deliverables.

Collaborate with regulatory and cross-functional teams to address health authority requests and submission requirements.

Perform end-to-end programming activities while acting as a subject matter expert and reliable team contributor.

Identify opportunities for process improvement and contribute to innovation within programming practices.

Mentor and coach junior programmers and support the development of team capabilities.

Requirements:

The ideal candidate has strong statistical programming experience within clinical research environments, with advanced SAS expertise and a solid understanding of pharmaceutical development processes. You should be comfortable working independently, collaborating globally, and managing complex technical deliverables.

Bachelor’s degree or higher in Statistics, Computer Science, Mathematics, Engineering, Life Sciences, or a related discipline.

4+ years of experience in clinical data programming within the biotechnology, pharmaceutical, CRO, or healthcare industry.

Strong SAS programming skills with experience working in clinical trial data environments.

Knowledge of additional programming languages such as R or Python is an advantage.

Strong understanding of clinical development processes, statistical concepts, and clinical trial principles.

Experience with regulatory submissions and knowledge of requirements such as NDA, ANDA, and related submission processes.

Extensive experience implementing CDISC standards, regulatory guidance, and therapeutic area user guides (TAUG).

Familiarity with regulatory documentation requirements and submission packages is preferred.

Strong analytical, problem-solving, and critical-thinking skills.

Ability to work independently while collaborating effectively with global interdisciplinary teams.

Excellent organizational, communication, and interpersonal skills.

Positive, proactive mindset with strong ownership, accountability, and teamwork abilities.

SAS certification is a plus.

Benefits:

Remote or hybrid work flexibility within India.

Opportunity to contribute to global clinical development programs.

Exposure to advanced statistical programming practices and regulatory processes.

Professional growth opportunities through technical leadership and mentoring responsibilities.

Collaboration with international teams across clinical research functions.

Supportive environment focused on innovation, continuous learning, and career development.

Opportunity to make a meaningful impact on healthcare research and patient outcomes.

Competitive compensation package and employee benefits according to company policies.

How Jobgether works: We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team. We appreciate your interest and wish you the best!  Why Apply Through Jobgether? 

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