Senior Biostatistician Fsp

5+ years

Not Disclosed

Remote, USA

10 March 19, 2025

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Who Are You?

As an experienced Biostatistician with a passion for clinical development and advanced statistical analysis, you are ready to support or lead Phase I-IV clinical studies. You bring enthusiasm and a drive to motivate teams, inspiring them to deliver exceptional work while collaborating effortlessly with clients. You are always pushing clinical development forward, striving for continuous improvement, and motivating others to do the same.

Sponsor-Dedicated Role:

Working fully embedded within one of our pharmaceutical clients, with the support of Cytel, you will be at the heart of our client’s innovation. As a Senior Biostatistician, you will be dedicated to one of our global pharmaceutical clients—a leader in next-generation patient treatments. This company fosters an environment where individuals are empowered to work autonomously, taking ownership of their roles. This is an exciting time to join and contribute to this new program.

Position Overview:

As a Senior Biostatistician, you will provide support for ad-hoc or exploratory analyses related to submissions or Health Authority inquiries. Exposure to regulatory work experience is a bonus, especially if you understand regulatory questions and can translate them into statistical problems while collaborating effectively with clinical and regulatory teams. You will support medium-complexity clinical trials, guiding projects from design to archival.

Responsibilities:

As a Senior Biostatistician, your responsibilities will include:

Providing statistical support for clinical studies.
Participating in the development of study protocols, including study design discussions and sample size calculations.
Reviewing CRFs and data review guidelines; developing statistical analysis plans (SAPs), including analysis dataset and TLG specifications.
Performing statistical analyses and interpreting statistical results.
Preparing clinical study reports, including integrated summaries for submissions.
Effectively communicating statistical methodology and decision implications.
Understanding and adhering to FDA regulations for clinical trial data reporting, including good clinical practice and guidelines for electronic submissions.
Contributing to the creation, maintenance, documentation, and validation of standards for programming tools, outputs, and macros.
Participating in the development of CRFs, edit check specifications, and data validation plans.
Reviewing and authoring data transfer specifications for external vendor data.
Collaborating with internal and external functions (e.g., CROs, software vendors, clinical development partners) to ensure project timelines and goals are met.
Reviewing and/or authoring SOPs and Work Instructions related to statistical programming practices.

Qualifications:

To succeed in this position, you will need:

A Master’s degree in statistics or a related discipline (Ph.D. preferred).
5+ years of experience supporting clinical trials in the Pharmaceutical or Biotechnology industry.
Experience working for a CRO is strongly desired.
Proficiency in sample size calculation, protocol concept development, protocol development, SAP creation, and preparing clinical study reports, including integrated summaries for submissions.
Strong SAS programming skills for QCing critical outputs, efficacy/safety tables, and working closely with programmers. Knowledge of R programming is a plus.
Solid understanding and implementation of CDISC requirements for regulatory submissions.
Experience in ADaM specifications generation and QC of datasets.
The ability to build strong internal and external relationships and motivate a regional or global team.
Effective communication skills to explain statistical methodologies and decisions in lay terms.

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Senior Biostatistician Fsp

Job Description

Who Are You?

Sponsor-Dedicated Role:

Position Overview:

Responsibilities:

Qualifications:

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