Remote Position

Senior Biostatistician, Clinical Trial Experience Required

🌍 Remote · United States 💼 Full-time

Job Description:

Assist with development and modification of department SOPs and work instructions
Train new Biostatistics employees and mentor junior Biostatisticians
Develop study bids and scope changes for prospective client RFPs
Present Biostatistics study execution tasks at capabilities presentations
Serve as primary statistical contact for internal and external project team members
Manage Biostatistics tasks within project timelines and communicate timeline changes
Identify and communicate changes in scope
Review case report forms and completion instructions
Provide input on database design and data-edit considerations
Develop or review Interim Analysis Plans and Statistical Analysis Plans
Develop or review SDTM and ADaM dataset specifications and mock tables, listings, and figures
Independently program derived datasets and TLFs and validate corresponding programs
Review programming by other team members
Develop or review statistical methods and results sections for reports, CSRs, and publications
Plan and design clinical studies, including endpoints, power analysis, randomization, blinding, and protocol statistical methods
Develop or review Randomization Plans and randomization programs or lists
Perform activities according to CTI SOPs, project conventions, GCP, and ICH guidelines
Maintain accurate work records and file statistics documents in the eTMF
Participate in departmental meetings

Requirements:

At least 4 years of related biostatistics experience in a pharmaceutical, CRO, or related statistical environment
Master’s degree in Biostatistics, Statistics, or a related field
CDISC, SDTM, and ADaM dataset mapping experience
BLA/NDA submission experience preferred
Regulatory representation experience preferred, including meeting preparation/attendance and regulatory communication follow-up
Therapeutic experience in transplantation, autoimmune diseases, kidney and liver disease, oncology, and rare disease preferred
Experience providing statistical consulting to internal/external clients preferred
Ability to work within Good Clinical Practice and International Conference on Harmonization guidelines
Knowledge of biostatistics SOPs and project-specific conventions
Ability to independently program derived datasets and TLFs and validate programs
Experience with Interim Analysis Plans, Statistical Analysis Plans, Randomization Plans, SDTM, ADaM, and clinical study reports

Benefits:

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