Associate Director, Biostatistics and Programming

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.

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:

• Tasks may include but are not limited to: 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.  The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.
• 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.
• 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. Explore additional opportunities on our careers page, visit http://www.worldwide.com/careers , or connect with us on LinkedIn .