Precision Life Sciences is seeking a Biostatistician that will represent Biostatistics on study teams, report study status to Biostatistics management, and perform, or oversee the performance of, all Biostatistics-related activities while ensuring the integrity of the data and analysis by adhering to all applicable regulatory requirements and Standard Operating Procedures (SOPs).

 

ESSENTIAL FUNCTIONS
· Assist with the development and modification of department SOPs and work instructions
· Train new Biostatistics employees; mentor and assist junior level Biostatisticians
· Research novel methodologies and provide methodological training, documentation, and support in implementation
· Provide statistical consulting to internal/external clients; review senior-level statistics work
· Develop study bids and changes in scope for Biostatistics tasks in response to prospective client’s requests for proposals (RFPs).
· Attend and present the Biostatistics study execution tasks at capabilities presentations.
· As the lead Biostatistician on the studies to which you are assigned, perform or oversee the following tasks:

• Act as primary statistical contact for internal and external project team members.
• Manage projects to ensure statistics tasks are performed within the entire project timeline. Keep Biostatistics management aware of changes to project timelines.
• Proactively identify and communicate changes in scope to the clinical project manager and Biostatistics management.
• Review case report forms (CRFs) and completion instructions.
• Give input to database design and data edit considerations necessary to collect and clean data.
• Develop or review Interim Analysis Plans (IAPs) and Statistical Analysis Plans (SAPs) as needed per the protocol.
• Develop or review program specifications – SDTM and ADaM dataset specifications and mock tables, listings, and figures (TLFs) – needed to perform the analysis defined in the IAP/SAP.
• Perform the statistical analysis by independently programming derived datasets and TLFs and validate the developer’s corresponding programs per department SOPs.
• Review other's programming.
• Develop or review statistical methods and results in sections of statistical reports, clinical study reports (CSRs), or publications.

Plan and design clinical studies, including:

• overall study design development
• outcome / endpoint determination
• power analysis / sample size estimation reports

 

Develop or review Randomization Plans and randomization programs or lists

· Carry out all activities according to SOPs and project-specific conventions within the framework of Good Clinical Practice (GCP) / International Conference on Harmonization (ICH) guidelines

· Rely on instructions and Biostatistics SOPs to ensure timely, standard, quality deliverables to customers
· Maintain accurate records of all work performed and ensure all relevant statistics documents are filed in the eTMF per the project-specific eTMF Plan
· Provide input to and participate in departmental meetings

 

 

COMPETENCIES · Excellent verbal and written communication skills
· Strong motivation to produce high-quality deliverables with an attention to detail
· Comprehensive knowledge of statistical software packages including SAS
· Comprehensive knowledge of appropriate usage of statistical tests
· Knowledge of medical terminology and drug nomenclature
· Knowledge of the drug development and clinical research process (Phase I-IV clinical trials), and real-world evidence studies process
· Knowledge of ICH guidelines and regulatory requirements as they relate to biostatistics activities
· Ability to work independently and be self-motivated
· Ability to work effectively and successfully in a team environment
· Ability to manage responsibilities across multiple simultaneous projects
· Ability to explain complex statistical concepts to non-statistical project team members in a manner in which they would come away with a basic understanding of the statistical concept
· Advance departmental statistical knowledge 

 

REQUIRED EDUCATION AND EXPERIENCE · 7 years of related biostatistics experience in either a pharmaceutical or CRO environment or other relatable statistical experience
· Master’s degree in Biostatistics, Statistics or related field
· CDISC SDTM and ADaM dataset mapping experience

 

PREFERRED EDUCATION AND EXPERIENCE · BLA/NDA Submission experience; regulatory representation (i.e., meeting preparation/attendance, follow-up with regulatory communication)

· Therapeutic experience in transplantation, autoimmune diseases, kidney and liver disease, oncology, and rare disease

Posted On: Tuesday, January 7, 2025