Associate Director, Biostatistics

This is a fully remote position, open to applicants in Germany, +7 more countries.

📋 Description

• Collaborate with internal program staff and sponsors on the statistical components of research protocols.

• Provide expert statistical consultation on protocol development, including randomization, sample size assessments, efficacy evaluations, and data reviews.

• Define and manage project timelines, ensuring that deadlines are consistently met.

• Guarantee the high-quality completion of project tasks for both internal and external clients.

• Review, approve, and create statistical analysis summaries and plans, encompassing planned analyses and mock-ups for data display.

• Oversee and/or conduct statistical analyses, which include hypothesis testing and modeling.

• Collaborate with Medical Writers to contribute relevant sections of clinical study reports.

• Serve as the project biostatistician, interfacing with clients and regulatory agencies.

• Supervise a program of studies.

• Assist in defining and upholding departmental standards, SOPs, and operational practices.

• Provide leadership, mentoring, and statistical support to Biostatistics personnel.

• Aid in the development of training materials and the delivery of training for Clinical Reporting staff.

• Present Clinical Reporting processes and procedures to clients and other interested parties.

• Assist with project-task and resource coordination across Biostatistics and serve as a backup during the Manager's absence.

• Perform other assigned duties.

⛳️ Requirements

• A Master's degree in Statistics, Biostatistics, or a related field with eight years of relevant experience in the CRO industry or biotech; or a Doctorate in Statistics, Biostatistics, or a related field with six years of relevant experience.

• Experience in data handling and analysis.

• Extensive experience in oncology drug development across a wide range of oncology indications.

• Proven expertise in applying advanced statistical methodologies throughout the clinical development lifecycle.

• Senior-level statistical review and oversight of SAPs, ADaM specifications, datasets, TLFs, and other study deliverables.

• Experience with regulatory submissions and interaction with regulatory agencies.

• Experience in participating in and leading bid defense meetings.

• Ability to mentor, develop, and support biostatistical staff across global regions.

• Strong customer engagement and relationship management skills.

• Knowledge of GCP, ICH, and FDA guidelines and regulations relevant to clinical research.

• Advanced understanding of statistical methods used in Phase I-IV clinical trials.

• Proficiency in SAS Base and SAS Stat.

• Familiarity with statistical software packages such as N-Query and S-Plus.

• Capability to work creatively and independently on complex assignments.

• Strong time management skills.

• Ability to work effectively and collaboratively with professional staff.

• Excellent verbal and written communication skills.

• This position is not eligible for UK visa sponsorship.

🏝️ Benefits

• Work from home.

• Opportunities for leadership development.

• Join an international team environment.

• Access to mentoring and professional development opportunities.

• Training materials and Biostatistics/Clinical Reporting training.

• Global collaboration opportunities across Europe and JPAC.