Associate Director, Biostatistics and Programming

Flex and Oncology Clinical Research Private Limited; Thiruvananthapuram; On-site; INR 3,500,000 - 7,500,000; Full time

Job summary

Worldwide Clinical Trials is seeking an Associate Director, Biostatistics and Programming, to oversee daily operations of the Biostatistics and Statistical Programming department. You will supervise staff, design and review analyses, and mentor teams to ensure high-quality deliverables across studies and programs.

You will lead strategic initiatives, support business development, and collaborate with senior leaders to manage budgets and timelines while maintaining regulatory and quality

Qualifications

• Master’s degree in biostatistics or related field.
• 10+ years of relevant work experience.
• 5+ years line management experience.
• Pharmaceutical CRO experience required.
• Experience with CDISC/SDTM/ADaM programming including SAS.

Responsibilities

• Provide oversight on multiple clinical research projects.
• Lead and mentor biostatistics and programming staff.
• Support business development and client interactions.
• Manage department budgets and timelines.
• Develop and implement departmental objectives and SOPs.

Skills

SAS programming

Biostatistics

Statistical programming

Leadership

Mentoring

Education

Master’s degree in biostatistics

Tools

CDISC SDTM ADaM

Job description

Who we are

We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence. We are Worldwide Clinical Trials, and we are a global team of over 3,500+ experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs – in the best possible way. Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.

Why Worldwide

We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands‑on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day.

Join us!

SUMMARY

The Associate Director, Biostatistics and Programming, is a key member of the Biostatistics and Statistical Programming department. The provide daily supervision of Biostatistics and Statistical Programming operations and personnel to ensure the achievement of departmental goals and levels. This role will plan, analyze, and summarize the results of individual clinical studies or groups of studies (integrated summaries)in accordance with Worldwide Standard Operating Procedures (SOPs) or study specific guidelines. They will manage and mentor biostatistics and programming staff, lead department initiatives, report out to senior leadership, participate in business development activities and assist functional leads in the financial plus operational oversight of their projects.

RESPONSIBILITIES

• Provide oversight on multiple clinical research projects.
• Support Leads in low/moderate/high complexity studies in various phases of development.
• Effectively manage broad-based projects such as NDA submissions or complex, multi-protocol programs, potentially coordinating activities across multiple locations.
• Provide technical expertise, in conjunction with internal and external team members, to design, implement, analyze, report, and validate clinical trials.
• Collaborates with internal and external project team personnel, as needed, to meet project deliverables and timelines and ensure accurate, statistically valid deliverables.
• Ensure adequate staffing of all project teams and help coordinate resources across the Department.
• Represent department and company in a multi-disciplinary setting, including project team meetings, client meetings/presentations, and bid defense meetings.
• Provide statistical and programming advice/recommendations regarding clinical study design/study endpoints, sample size requirements, statistical methodology for the study protocol and clinical study report, programming strategy and document review/approval.
• Oversee all biostatistical and statistical programming activities, including statistical analysis plan development, database specification, reporting specification, statistical programming analysis, and statistical summary/report writing.
• Maintain awareness of project budgets and tasks, and effectively communicate the status of such tasks to Finance and/or senior Leadership.
• Help staff identify resource or scope of work changes.
• Lead implementation of departmental objectives and strategies, including but not limited to SOP development, training, professional development, standardizations, and team building activities.
• Attend and contribute to continuing education programs, professional meetings, and other career development activities.
• Assist in marketing and business development opportunities as needed.
• Position will have management responsibilities.
• Development, oversight, and direction of departmental staff which may include interviewing, Managerial Requirements/ terminations, training, personal growth, retention plans, coaching/performance management, goal setting, & salary.
• Perform other duties as assigned.

OTHER SKILLS AND ABILITIES

• Knowledge of clinical trial study design and multiple therapeutic areas.
• Advanced knowledge of SAS and other specialist software.
• Able to work independently and lead various teams and committees.
• Lead study team meetings as needed.
• Capable of conducting exploratory statistical analyses using statistical software packages.
• A high degree of accuracy and attention to detail.
• Proficient with Microsoft Office Suite.
• Excellent written and oral communication skills.
• Excellent presentation skills.
• Strong organizational, problem-solving, and analytical skills.
• Ability to manage priorities and workflow.
• Versatility, flexibility, and a willingness to work within constantly changing priorities.
• Proven ability to handle multiple projects and meet deadlines.
• Strong interpersonal skills.
• Global communication and time zone awareness.
• Ability to work effectively with a diversity of individuals at all organizational levels.
• Commitment to excellence and high standards.
• Creative, flexible, and innovative team player.
• Ability to travel for meetings or training activities.
• Ability to travel internationally may be required.
• Develop and guide implementation of departmental objectives and strategies.
• Proven ability to effectively manage and mentor junior staff.
• Ability to effectively engage with executive leadership.
• Experience with financial and budget management.

REQUIREMENTS

• Education: Master’s degree, equivalent, or higher in biostatistics or a related field. A satisfactory combination of education and experience may be accepted as a substitute for the specific education and experience listed above.
• Experience: A minimum of 10+ years of relevant work experience.
• A minimum of 5+ years line management experience.
• Previous experience in a pharmaceutical research or CRO setting required.
• Previous experience in multiple therapeutic areas, including oncology.
• Hands on Experience with CDISC/SDTM/ADaM Programming including but not limited to SAS: Data Step Manipulation, Merge, Sort, Transpose, Reporting (Proc Report), Comparison (Proc Compare), Error Checking (Log resolution), modeling, missing data handling approaches/procedures, figure development.
• Capable of conducting exploratory statistical analyses using statistical software packages.
• Experience developing custom SAS programs.
• Experience with P21 reporting and DEFINE, SDRG, ADRG development.
• Creation of annotated CRFs Base or Advance SAS certification preferred.
• Required Certifications: N/A.

Promotion to the next level is not automatic based on years of experience. Personnel are evaluated on proven competency, level of responsibility, and ability to work independently.

We love knowing that someone is going to have a better life because of the work we do.

To view our other roles, check out our careers page at Discover a world of difference at Worldwide! For more information on Worldwide, visit www.Worldwide.com or connect with us on LinkedIn.

Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity.

We know that when our employees feel appreciated and included, they can be more creative, innovative, and successful.

We’re on a mission to hire the very best and are committed to creating exceptional employee experiences where everyone is respected and has access to equal opportunity.

We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status or other class protected by applicable law.

This is who we are.

We’re a team of clinicians, scientists, and researchers who want to make healthcare better.

We were founded on an unwavering commitment to authentic, personalized attention.

And today, as CROs consolidate and the industry changes rapidly, that personalized attention is more important than ever.

We all came to this industry for different reasons, from different walks of life.

If you ask any one of us why we’re here, you’ll get a different answer.

And that’s what makes us special.