Associate Director, Biostatistics and Programming

Worldwide; Thiruvananthapuram; On-site; INR 2,500,000 - 4,500,000; Full time

Job summary

Worldwide Clinical Trials in Trivandrum is seeking a senior Associate Director, Biostatistics and Programming to lead statistical strategy across studies, ensuring rigorous deliverables and regulatory readiness.

You will mentor teams, coordinate with sponsors and global stakeholders, manage resources and timelines, and shape departmental priorities while advancing oncology programs.

Qualifications

• 10+ years in biostatistics and programming with at least 5 years in people management.
• Experience in pharma CRO environments and oncology programs.
• Expert SAS/CDISC with CDISC SDTM/ADaM and regulatory deliverables.
• Strong leadership, cross-functional collaboration, and client engagement.

Responsibilities

• Lead biostatistics and programming across multiple studies and phases.
• Plan, analyze, interpret, and report study results per standards.
• Provide statistical strategy for design, endpoints, sample size, and reporting.
• Manage regulatory submissions and multi-protocol programs.
• Collaborate with sponsors and cross-functional teams to ensure quality outcomes.
• Oversee staffing, budgeting, and timelines across projects.
• Represent department in meetings and bid defenses.
• Drive process improvements and training initiatives.
• Mentor and develop staff.

Skills

Leadership

Stakeholder management

Communication (English)

Analytical thinking

Project management

Financial management

Education

Master's degree or higher in Biostatistics or related field

Tools

SAS programming (CDISC)

Job description

Join a global Contract Resource Organization (CRO) where innovation meets purpose. At Worldwide Clinical Trials, we're driven by a shared commitment to improving lives through high-quality clinical research. Our teams are empowered to think creatively, take ownership, and deliver meaningful work that helps bring life-changing therapies to patients around the world.

With more than 4,000 professionals across the globe, we foster a collaborative and inclusive environment where diverse perspectives are valued, growth is encouraged, and every contribution makes an impact. Whether you're building your career or bringing years of experience, you'll have the opportunity to learn, grow, and help shape the future of clinical research.

Make an Impact as an Associate Director, Biostatistics and Programming at Worldwide

• Play a pivotal role in shaping the statistical and programming strategy behind clinical research programs across multiple studies and therapeutic areas. In this leadership position, you'll oversee biostatistics and statistical programming activities, ensuring high-quality, scientifically rigorous deliverables that support successful clinical development.
• You’ll lead and mentor teams, drive operational excellence, and collaborate with internal and external stakeholders to deliver complex clinical projects on time and within scope. From study design through reporting and submission activities, your expertise will help guide critical decisions and contribute to meaningful advancements in clinical research.
• As a key member of the Biostatistics and Statistical Programming department, you'll also influence departmental strategy, resource planning, business development efforts, and organizational growth while partnering closely with senior leadership.

Where You'll Work

• This is a role open to candidates based in Trivandrum. You will collaborate with global teams across multiple time zones.

What You'll Do

• Lead and oversee biostatistics and statistical programming activities across multiple clinical research projects and development phases.
• Direct the planning, analysis, interpretation, and reporting of clinical study and integrated study results in accordance with established standards and guidelines.
• Provide strategic statistical and programming expertise for study design, endpoint selection, sample size determination, protocol development, and clinical study reporting.
• Manage complex initiatives, including regulatory submissions and multi-protocol programs, while coordinating activities across teams and locations.
• Collaborate with sponsors, clients, and cross-functional stakeholders to deliver accurate, high-quality, and statistically sound project outcomes.
• Ensure appropriate staffing, resource allocation, and operational support across project teams while monitoring scope, budgets, and timelines.
• Represent the department in project meetings, client presentations, and bid defense activities, serving as a trusted subject matter expert.
• Drive departmental initiatives focused on process improvement, SOP development, training, standardization, professional development, and team engagement.
• Manage, mentor, and develop biostatistics and programming staff through coaching, performance management, goal setting, and career development activities.

What You’ll Bring

• Master's degree or higher in Biostatistics or a related field, or an equivalent combination of education and experience.
• 10+ years of relevant biostatistics and statistical programming experience, including at least 5 years of people management experience.
• Previous experience within a pharmaceutical research organization or CRO environment.
• Experience supporting multiple therapeutic areas, including oncology.
• Advanced expertise in SAS programming, including CDISC, SDTM, ADaM, custom SAS program development, statistical reporting, data manipulation, validation, and submission deliverables.
• Experience with P21 reporting, DEFINE documentation, SDRG, ADRG development, and creation of annotated CRFs.
• Strong leadership, stakeholder management, presentation, analytical, problem-solving, and financial management skills with the ability to engage effectively with executive leadership.
• Proficiency in English, with excellent written and verbal communication skills and the ability to collaborate across global teams and time zones.

Discover the Difference

We love knowing that someone is going to have a better life because of the work we do. Discover the Difference at Worldwide Clinical Trials.