Principal Biostatistician

Principal Biostatistician

POSITION SUMMARY:

This role participates in the statistical support of clinical trial research studies that further the mission, vision, and strategic plan of the organization. This role is responsible for mentoring the biostatistician team members on clinical trial statistical support, providing oversight of trial activities and performing all statistical support of assigned clinical trials. Additionally, this person will contribute to the training of new biostatisticians and will act as a mentor and leader to the team providing guidance to junior members of the team.

ACCOUNTABILITIES:

Leadership accountabilities:

• Leverage statistical expertise; Develop complex analysis strategies and execute them using efficient programming techniques (software: SAS, R).
• Share knowledge; Provide input to analysis plans, protocol design, statistical reports, statistical sections of clinical reports.
• Impact the process; Be a proactive advisor for all types of analysis from the proposal process through the project life cycle.
• Take quality seriously; Review analysis data sets and quality control all types of statistical analysis deliverables.
• Coach and mentor; Train and uplift junior members of the department.
• Develop efficiencies and new processes; Create and modify department SOPs and work instructions.
• Investigate novel approaches (e.g., new applications of adaptive design) for designing and analyzing clinical research studies.

Statistical accountabilities:

• Act as lead statistician on multiple protocols simultaneously (Phase I-IV) starting from study design conception through statistical analysis and final submissions.
• Develop statistical design during protocol development including endpoint selection, statistical analysis methods, considerations for interim analyses, design of safety monitoring rules, sample size and power calculation and safety monitoring.
• Author randomization plan and produce randomization schedules; lead blinding and unblinding processes.
• Write statistical analysis plan (SAP) and develop table, listing and figure (TLF) shells.
• Guide and review statistical programming including programming plans, specifications and codes.
• Perform or review statistical analysis (interim, final, closeout analyses).
• Independently program and clean derived datasets and TLFs; Perform programming validation per department SOPs.
• Write statistical sections of the protocol, clinical study report (CSR), presentations and manuscripts; Provide statistical interpretations of reports.
• Collaborate with cross-functional teams on case report form review, CRF completion guidelines, data cleaning strategies, blinding management, data monitoring.
• Interact with Data and Safety Monitoring Boards (DSMBs), including presenting interim study progress.
• Interact with external sponsor(s) and statistical collaborators outside the organization.
• Review and approve SDTM mapping specifications and ADaM derivation specifications.
• Review, approve, annotate CRF for SDTM.

Additional Skills & Qualifications

REQUIRED QUALIFICATIONS:

Knowledge of:

• Clinical trial methodology for Phase I-III clinical trial designs.
• Clinical data management processes and tools (Medidata Rave and Veeva preferred).
• CDISC standards (SDTM and ADaM).

Ability to:

• Independently solve problems and make decisions.
• Explain statistical concepts to non-statisticians to enhance their understanding of the analytical approach.
• Independently apply advanced analytical and programming skills for statistical analysis and sample size calculations.
• Employ excellent organization, written and communication skills, including the ability to provide meticulous documentation of processes and organize materials in a transparent manner.
• Act in a collaborative spirit and exhibit healthy communication skills with all collaborators

Education/Experience:

• PhD degree in relevant field, with 5 years experience in statistical design and analysis of Phase I-IV clinical trials
• Master's degree in relevant field with 8 years experience in statistical design and analysis of Phase I-IV clinical trials.

PREFERRED QUALIFICATIONS:

(Additional qualifications that may make a person even more effective in the role, but are not required for consideration)

• Preference given to candidates with working knowledge of GCP and FDA regulations, experience working in the pharmaceutical/medical device industry and working knowledge of SDTM/ADaM standards.
• Excellent interpersonal skills that can enable enjoyable collaboration with diverse study staff and investigators.
• Demonstrated success working/collaborating with diverse populations in a role that has focused on improving health equ

Other Notes:

• Strong leadership
• Culture fit
• Core of the team is very collaborative
• Willing and open to hearing all ideas
• More technical leader vs operational leader
• Digging into the technical work
• They want someone there long term
• Not the right role for someone wanting people leadership; not the right role for someone that was just an Assoc Director or Director

Experience Level

Expert Level

Job Type & Location

This is a Permanent position based out of Minneapolis, MN.

Pay and Benefits

The pay range for this position is $140,000.00 - $150,000.00/yr.

Have documents for candidates: Total Rewards Offerings FY26 - Have document Operating Principles & Values

Workplace Type

This is a fully remote position.

Application Deadline

This position is anticipated to close on May 28, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email [email protected] for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.