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Careers > Manager/Associate Director, Biostatistics

Position Summary:    

The Manager/Associate Director, Biostatistics provides leadership to the statistical activities for several clinical studies.  Duties include providing technical guidance to Biostatisticians and statistical programmers and to promote interdisciplinary understanding within the groups of other departments and project teams, wherever possible.

Essential Functions/Responsibilities:

• Participate in clinical study protocol design from conception, prepare the study statistical analysis plan (SAP), Mock-Up Tables, and participate in team review of protocols for Phase I, II, III trials.
• Review case report forms (CRFs) and ensures their design meets the protocol criteria and captures all data required to support a high quality database and the planned analysis.
• Act as internal expert on statistical study methodologies for clinical, clinical pharmacology, and non-clinical studies; advise team members accordingly.
• Work with CRO staff for all ongoing activities related to data management and statistical analysis of clinical trial data.
• Perform plausibility checks on data and take the appropriate action to resolve inconsistencies and to handle implausible values during analysis;
• Contribute to relevant statistical sections of clinical study reports and scientific presentations; participate in team review of these documents.
• Contribute to relevant statistical sections of IND, NDA and other documents for regulatory submission and interact directly with the FDA and foreign regulatory authorities.
• Establish and negotiate accurate timelines with internal and external team members for completion of study-related statistical activities.
• Review and approve tables, listings, and figures (TLFs) in collaboration with statistical programmers to ensure accurate and appropriate analysis and results.
• Conduct and participate in validation and quality control of project deliverables as necessary.

Qualifications and Abilities:

•  Ph.D. or M.S in biostatistics, statistics and/or other relevant scientific disciplines.
•  At least 8-10 years relevant work experience at biotech or pharmaceutical companies with at least 2 years of management responsibility.
• Knowledgeable in FDA, EMEA and ICH  regulatory guidelines, clinical development processes, and validation processes.
• Essential to have a broad, in-depth knowledge of clinical trial design, database design and management, statistical programming, and data analysis.
• Essential to have experience/ training in QC related to data management and statistics.
  
• Essential to have knowledge of SAS and other statistical packages.
  
• NDA/ MAA, CTD, and ISE/ISS experience desirable.
  
•  Prior experience in Oncology is desirable.
  
• FDA Advisory Committee preparation/ presentation experience desirable.
  
• Excellent communication, organization, management, interpersonal and scientific writing skills required for working successfully in a cross-functional team environment.
  
• Proven track record in forming and managing a functional biometric team to support multiple clinical and preclinical studies.

Please send all inquiries to careers@proteolix.com. No agencies please.

Proteolix offers competitive compensation and benefits, equity participation, and an interactive, professional environment that recognizes/rewards achievements. We are proud to be an equal opportunity employer.

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