Lead Data Manager

Position Background:

We are seeking a dynamic and strategic Lead Data Manager to lead 1 or more therapeutic areas with full accountability for statistical activities including program level planning, protocol development, SAP and statistical outputs; will collaborate with partner functions in Clinical Development Department (e.g., Clinical Operation, Clinical Research, Regulatory) and oversee the vendor counterparts. The ideal candidate has demonstrated expertise and leadership on Biostatistics activities to support clinical development, regulatory submissions, and inspections.

Responsibilities:

• Participate in a number of new drug development programs as subject matter expert and provide technical leadership in the design and execution of clinical trials and statistical analysis plans.
• Serve as the Biostatistics lead for one or more studies/programs.
• Monitor assigned work progress to insure successful deliverables against goals and timelines.
• Work with the Study Management Team to provide input to study design and the statistical section of clinical trial protocols.
• Oversee production of, contribute to, or prepare statistical sections of protocols and statistical analysis plans.
• Participate in planning for FDA/EMA meetings and the preparation of associated responses.
• Perform quality control checks of statistical analyses and SAS programs as needed.
• Provide guidance to Statistical Programmers on SDTM/ADaM and TLFs specifications development and programming.
• Provide input to database requirements and work closely with Clinical Data Manager to insure data quality standards are met.
• Work as part of a collaborative, cross-functional team with members from other disciplines.
• Participate in other activities and meetings to support Biostatistics and the Development team as necessary.

Qualifications:

• PhD in statistics, biostatistics, or related field with at least 8 years of experience in biopharmaceutical industry; or MS in statistics, biostatistics, or related field with 10 years of experience in biopharmaceutical industry.
• Experience working on NDA/BLA/MAA development and submissions.
• Experience working on all phases of clinical trials.
• Preferred Qualifications

1. Experience working on Phase 3 clinical trials.
2. Hands-on experience working on CSRs and Clinical Summary documents such as Integrated Summary of Safety and Efficacy
3. Understanding of ICH GCP as well as knowledge of industry practices and standards.

General Competencies:

• Able to communicate effectively in English, both verbally and in writing
• Possess a positive roll-up-the-sleeves attitude and optimistic outlook
• Represents the organization in a positive and professional manner
• Strong ability to work in a fast-paced team environment with fluctuating priorities, and collaborate effectively with others
• Excellent organizational and time management skills with ability to set own priorities in a timely manner
• High degree of flexibility and adaptability
• Basic computer skills required, such as knowledge of MS Word, Excel, PowerPoint, and Outlook
• Must be able to work as needed to meet tight deadlines and at peak periods
• Self-motivated and organized critical thinker with solid interpersonal and business communication skills
• Demonstrated ability to work in a cross functional team
• Adheres to company and facility specific policies and procedures, including SOP, training and meeting requirements
• Always observe safety precautions and regulations in all areas where duties are performed
• Responsible for reporting all safety hazards and potential unsafe working conditions
• Reports to work on time and as scheduled