Principal Biostatistician

Position Summary:

Job Description

Provides statistical support for all phases of clinical development. Specific responsibilities include writing and reviewing statistical sections of protocols, writing and reviewing statistical analysis plans including complex study designs, conducting statistical analyses and presenting results to project teams and sponsors, and developing SAS programs for tables, listings, figures and analysis datasets in accordance with Precision and/or sponsor procedures or study specific guidelines.

Essential functions of the job include but are not limited to:

Generate and/or verify randomization schedules

Develop and review statistical methods of the clinical study protocol including

complex study designs

Provide and/or verify sample size calculations. Perform or assist with advanced

calculations including adaptive design

Provide input into development of case report forms (CRFs)

Author statistical analysis plans, including development of table, figure and listing

shells, complex study design and late phase

Review statistical analysis plans written by other biostatisticians

Generate analysis datasets, tables, figures, and listings to support the analysis of

clinical trials data using SAS

Perform quality control for statistical based SAS programs and other study documents

(e.g., presentations and reports)

Provide or supervise programming and statistical support to supplemental or exploratory analyses for regulatory agencies or any other internal and external ad-hoc requests Ability to serve as a biostatistical consultant to company staff globally, with

understanding of varying regional perspectives

Review output across programs to ensure consistency. Provide statistical analysis and reports to Data Monitoring Committees (DMCs) as the unblinded biostatistician Review statistical sections of clinical study reports Work directly with sponsors, project managers, and external vendors on statistics related project components. Interact directly with study team Interact directly with sponsors Lead all statistical activities for study within timelines Independently perform budget health review on projects and review monthly invoices Perform oversight responsibilities on projects for other biostatisticians Assist with budget development and present at bid defense meetings Participate in the development and maintenance of departmental procedures and

standards (templates, SOPs, WIs etc.) Review study tasks to ensure study being conducted in line with agreed budget;

identify change in scope Other duties as assigned

Qualifications

Minimum Required:

Master's degree or equivalent in Statistics, Biostatistics, or related field with 10+ years

experience; PhD degree in Statistics, Biostatistics, or related field with 7+ years

experience

Other Required:

Experience with SAS

Knowledge of industry standards such as the ICH guidelines, CDISC data structures,

21 CFR Part 11, and FDA guidelines

Broad knowledge and superior understanding of advanced statistical concepts and

techniques

Preferred:

Experience with Oncology and rare diseases

Broad experience with late phase and/or submissions

Experience in consulting with clients on study design

Superior understanding of a specific therapeutic area and/or statistical methodology

(eg, adaptive design, missing data)

Skills:

Mastery of statistical principles underlying clinical trials

Mastery of SAS programming skills and familiarity with other packages

Outstanding statistical skills

Excellent consultative skills

Excellent organizational skills, time management, and ability to coordinate workload

and meet established deadlines.

Excellent communication and interpersonal skills to effectively interface with others.

Excellent problem-solving skills

Excellent presentation skills

Competencies:

Sound judgment/decision making

Ability to establish and teach others to maintain effective working relationships with coworkers, managers and clients Service oriented, accountable and flexible Competency in written and spoken English Follow and train others on applicable regulations, including FDA, ICH, and Precision Policies and Procedures

Any data provided as a part of this application will be stored in accordance with our

Privacy Policy.

For CA applicants, please also refer to our

CA Privacy Notice . Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at Recruitment Fraud Warning: Please be aware that fraudulent individuals and websites may impersonate Precision Medicine Group or its affiliates and attempt to obtain personal, financial, or banking information through fake job postings or employment offers. Precision Medicine Group will never request payment, banking details, or other sensitive financial information as part of the recruitment process. If you believe you have been targeted by a recruitment scam, we encourage you to report the incident to your local law enforcement authorities, consumer protection agency, or relevant cybercrime reporting organization in your country. Please also notify us at Candidates must be legally authorized to work in the country of employment without employer sponsorship. Find Jobs in United