Ephicacy - Associate Director - Biostatistics & Programming (14-18 yrs)

Key Responsibilities:

Technical Leadership:

- Provide strategic direction and technical support to programmers and analysts.

- Guide the enhancement and development of data collection, provisioning, and review tools.

- Lead the resolution of complex technical challenges.

- Collaborate with Statistical TA leads and statisticians to design:

- Standard data structures

- ADaM mapping specifications

- TFL shells

- Oversee the production and validation of these deliverables.

Team Management & Development:

Manage team performance, including:

- Performance appraisals

- Career development plans

- Disciplinary procedures

- Conduct employee training and development programs.

- Mentor team members to enhance their skills and knowledge.

- Optimize resource allocation to maximize team productivity and efficiency.

Regulatory Compliance:

- Ensure compliance with all relevant regulatory requirements (e.g, FDA, EMA).

- Adhere to integrated management systems standards (ISO 9001, 27001, 22301).

- Participate in internal and client audits.

- Stay abreast of industry trends and best practices.

Resource Management:

- Manage team resources, including hiring, terminations, and contractor management.

- Oversee line management responsibilities, including performance management and staff development.

Qualifications:

- Advanced degree in a relevant field (e.g, Statistics, Computer Science, Biostatistics).

- 14-18 years of experience in biostatistics and programming within the pharmaceutical or biotechnology industry.

- Proven experience leading and managing high-performing teams.

- Strong technical expertise in statistical programming languages (e.g, SAS, R).

- In-depth knowledge of clinical trial data management and analysis.

- Experience with data standards (e.g, CDISC) and regulatory guidelines.

- Excellent communication, interpersonal, and problem-solving skills.

Preferred Skills:

- Experience with data visualization and reporting tools.

- Knowledge of cloud computing platforms (e.g, AWS, Azure).

- Experience with Agile methodologies