Associate Director-Biostats

The Associate Director, Biostatistics and Statistical Programming is a key leader of the Flex Operations, Biostatistics and Statistical Programming Team, providing 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) and coordinate the development and review of regulatory submissions (e.g., NDAs) in accordance with Catalyst Biostatistics and/or sponsor Standard Operating Procedures (SOPs) or study specific guidelines.  and mentor departmental staff. The role requires effective collaboration with internal and external stakeholders to meet project deliverables, timelines, and budgets. 

Position Responsibilities/

Accountabilities:

- Supervise and mentor biostatistics and statistical programming personnel, including training, performance management, and career development. 

- Provide oversight for statistical programming activities, including the development of statistical tables, listings, figures, and submission-ready data packages. 

- Lead biostatistical activities such as protocol review, statistical analysis plan (SAP) development, programming specifications, and interpretation of clinical trial data. 

- Plan, analyze, and summarize individual clinical studies and integrated summaries for regulatory submissions. 

- Represent the company in multidisciplinary project team meetings, client presentations, and bid defense meetings. 

- Provide statistical and programming advice on clinical study design, endpoints, sample size requirements, and statistical methodologies. 

- Manage departmental objectives, including process improvement, SOP development, and standardization of workflows.

- Maintain awareness of project timelines and budgets, ensuring effective resource allocation and timely delivery of deliverables. 

- Collaborate with internal and external teams to ensure quality, integrity, and efficiency in project activities. 

- Contribute to ongoing departmental and organizational improvements by implementing innovative strategies and methodologies.

Provide executive 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 advanced technical expertise, in conjunction with internal and external team members, to design, implement, validate, and maintain project reporting applications that are supported by the department.

Assist in marketing and business development opportunities as needed.

Managerial Requirements/ Responsibilities:

· Oversee departmental staff, including hiring, training, performance evaluations, retention plans, and salary recommendations. 

· Provide leadership to foster a positive, team-oriented environment and professional growth opportunities. 

· Conduct recurring staff meetings and effectively manage priorities, workflows, and goals.

. Ensure accurate and efficient resource management for all projects

Position Qualification Requirements:

Education:

• Master's degree or higher in Biostatistics, Computer Science, Mathematics, 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 4+ years line management experience.

• Previous experience in 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

Required Certifications: 

Base or Advance SAS certification preferred.

Required Skills:

• Knowledge of clinical trial study design and multiple therapeutic areas, including oncology.

• 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.