Offer summary

Qualifications:

PhD in Biostatistics or related field with at least 5 years of relevant experience in pharmaceutical or biotech drug development., Strong understanding of clinical development lifecycle, including regulatory submission and post-approval activities., Proficiency in statistical software such as SAS and R, with familiarity in East and Spotfire., Excellent communication skills and ability to collaborate effectively across functional teams..

Key responsibilities:

Provide statistical and operational input for study and program design, including protocols and analysis plans.

Collaborate with cross-functional teams to support drug development and ensure statistical integrity of deliverables.

Lead evaluation of innovative study design and analysis methods.

Oversee statistical and programming deliverables from CROs and assist in vendor selection.

Job description

We are seeking a stellar biostatistician to join our rapidly growing team to support clinical studies across our expanding portfolio. As an internal expert in biostatistics, you will provide technical leadership and biostatistical input to closely collaborate with other functional teams, including Clinical Development and Operations, Regulatory, Commercial, Program Management and others.

Responsibilities
• Provide sound statistical and operational input, including study and program design, writing of the protocol sections, statistical analysis plans (SAP), clinical study reports (CSR), regulatory documents or scientific publications
• Partner with cross functional teams to provide strategic biostatistics input to support entire drug development process; ensure statistical integrity of all key deliverables
• Provide statistically sound scientific methodology for study design and data analysis input to meet project objectives in accordance to regulatory guidance and industry standards
• Collaborate with the programming and data management functions to ensure appropriate data collection and reporting
• Provide leadership in evaluating alternative or innovative methods of study design and analysis
• Assist in efforts to identify, develop and implement departmental standards, applications, processes and training
• Oversees statistical and programming deliverables by CROs
• Assist in identifying consultants and the selection of service providers

Requirements:
• PhD in Biostatistics or a related field with a minimum of 5 years of relevant experience in pharmaceutical or biotechnology drug development
• Understanding and experience with various aspects of a clinical development life-cycle, leading up to regulatory submission and post-approval activities
• Experience interacting with and overseeing biometrics services of CRO vendors
• Proficiency in the use of statistical software including SAS and R at minimum; familiarity with East and Sportfire
• Excellent verbal and written communication skills
• Knowledge of pharmaceutical clinical development processes and ability to effectively apply technical principles and methods to clinical drug development
• Effective in communication and team collaboration, influencing across different functional lines
• Knowledge of cross-functional department functions/roles within a drug development company

Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws. In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.

By applying to the position, you acknowledge that your information will be used by Kaztronix in processing your application.

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