Principal Statistician

2 Months ago • 5 Years + • Data Analyst • $169,000 PA - $243,000 PA

Job Summary

Job Description

The Principal Statistician leads statistical deliverables for assigned clinical trials. Responsibilities include recommending research design, acting as a liaison with committees and experts, authoring sections of clinical research protocols (endpoint specification, sample size, randomization plans, statistical analysis plans), preparing clinical study reports and regulatory documents, performing statistical QC, reviewing CRFs, collaborating on publications, and leading dataset generation. The role involves using SAS/R, providing programming support, identifying productivity improvements, and interacting with various teams. The ideal candidate will possess strong statistical expertise, excellent communication skills, and familiarity with FDA regulations.
Must have:
  • Master's in Statistics/Biostatistics
  • 5+ years clinical trial analysis experience
  • SAS/R programming proficiency
  • Clinical study report authorship
  • Regulatory document preparation
  • FDA regulatory knowledge
Good to have:
  • Experience with device pre-market approvals
  • ICH/GCP understanding
  • Experience analyzing complex study objectives
Perks:
  • Collaborative teamwork environment
  • Generous benefits package (medical, dental, vision, life insurance, 401k, stock purchase plan, paid parental leave)
  • Paid holidays and vacation time

Job Details

General Summary
Under general supervision of the Statistics Manager or higher, the Principal Statistician is the lead statistician on clinical studies and is responsible for all statistical deliverables for assigned trials. This person will provide scientific and statistical expertise for the design, analysis, and reporting of scientific research trials. This person will also represent Statistics on project teams to provide functional area input to and ensure alignment with functional management.

Specific Duties and Responsibilities
•Independently recommend appropriate research design, definition of patient populations, measurement of outcome variables, and hypothesis development on assigned trials. *
•Act as the liaison for statistical issues with steering and/or data monitoring committees, investigators, and medical/scientific experts. *
•Assume responsibility for individual studies, author and provide input on relevant sections of clinical research protocols, including endpoint specification, sample size determination and justification, randomization plans, statistical analysis plans, interim analysis, and stopping rules. *
•Prepare key sections of clinical study reports and various regulatory documents.
•Drive submission activities and documents, provide input on responses to regulatory authorities and other device development activities, as required. Author statistical analysis plans, including development of table and listing shells. Review statistical analysis plans written by contract or junior statisticians. *
•Prepare key sections of clinical study reports and regulatory documents. Perform statistical QC of final clinical study reports. *
•Review CRFs to ensure consistency with protocol and adequacy in collecting data to meet objectives and statistical analyses defined in the protocol.
•Collaborate with study leads and investigators in the preparation of abstracts, oral and poster presentations, and publications relating to the results of clinical studies. *
•Participate in planning and execution of randomization and un-blinding activities. *
•Provide data for review by outside safety panels such as Data Safety Monitoring Boards. *
•Represent statistics function in discussions at conferences and investigator meetings.
•Lead the generation/validation of analysis datasets, tables, figures, and listings to support the submission of clinical trial data using SAS/R.*
•Use statistical software such as SAS and R to create and maintain listings, tabulations, graphical summaries, and formal statistical estimates and tests. *
•Provide programming support to supplemental or exploratory analyses for regulatory agencies or any other internal and external ad-hoc requests. *
•Responsible for identifying opportunities for productivity improvements and formulating implementation plans. Independently develop new processes. *
•Interact with data management, statistical programmers, clinical affairs, medical affairs, regulatory affairs, quality assurance staff, and external data analysis vendors.
•Serve as the as the SME for statistical methods, collaborate with other functional groups and explain statistical concepts in an easily understandable way to non-statisticians and provide adequate statistical justifications for actions/decisions/statements, when required.
•Remain current with statistical methods and trial design issues. Proactively implement new statistical methods on assigned trials and share such knowledge with other company statisticians.
•Adhere to the Company’s Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures. *
•Understand relevant security, privacy and compliance principles and adhere to the regulations, standards, and procedures that are applicable to the Company. *
•Ensure other members of the department follow the QMS, regulations, standards, and procedures.*
•Perform other work-related duties as assigned.
*Indicates an essential function of the role

Required Qualifications
Minimum Education and Experience:
•Masters’ degree in Statistics, Biostatistics, Math or related field with 5+ years of
experience, or equivalent combination of education and experience.
•5+ years of experience in clinical trial analysis in a medical device or pharmaceutical environment.
•Working knowledge of computer programming and software programs (e.g., SAS, R) required.

Additional Qualifications:
•Prior experience working on device pre-market approvals, IDE, and HDE submissions to CDRH is preferred.
•Understanding of FDA regulatory requirements and ICH/GCP preferred.
•Experience analyzing complex study objectives and developing appropriate analysis specifications and plans.
•Experience writing, reviewing and approving statistical analysis plan (SAP) from the clinical protocol and other study specific documents.
•Experience of developing statistical reports for industry conferences, regulatory submissions, and for internal reviews.
•High degree of accuracy, organizational skills and attention to detail are essential.
•Excellent oral, written, and interpersonal communication skills.
 
Working Conditions:
•General office environment.
•May have business travel from 0% - 15% to research or laboratory hospitals.
•Potential exposure to blood-borne pathogens.
•Must be able to move between buildings and floors.
•Must be able to remain stationary and use a computer or other standard office equipment, such as a printer or copy machine, for an extensive period of time each day.
•Must be able to read, prepare emails, and produce documents and spreadsheets.
•Must be able to move within the office and access file cabinets or supplies, as needed.
•Must be able to communicate and exchange accurate information with employees at all levels on a daily basis.

Annual Base Salary Range:  $169,000 - $243,000  
This is the pay range for a mid-cost labor market. If hired in another region, there will be a difference in pay range. We offer a competitive compensation package plus a benefits and equity program, when applicable. Individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location.


What We Offer
•A collaborative teamwork environment where learning is constant, and performance is rewarded.
•The opportunity to be part of the team that is revolutionizing the treatment of some of the world's most devastating diseases.
•A generous benefits package for eligible employees that includes medical, dental, vision, life, AD&D, short and long-term disability insurance, 401(k) with employer match, an employee stock purchase plan, paid parental leave, eleven paid company holidays per year, a minimum of fifteen days of accrued vacation per year, which increases with tenure, and paid sick time in compliance with applicable law(s).
 
Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures, and markets novel products and has a broad portfolio that addresses challenging medical conditions in markets with significant unmet need. Penumbra sells its products to hospitals and healthcare providers primarily through its direct sales organization in the United States, most of Europe, Canada, and Australia, and through distributors in select international markets. The Penumbra logo is a trademark of Penumbra, Inc.
 
Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, age, disability, military or veteran status, or any other characteristic protected by federal, state, or local laws.
 
If you reside in the State of California, please also refer to Penumbra's Privacy Notice for California Residents.
 
For additional information on Penumbra’s commitment to being an equal opportunity employer, please see Penumbra's AAP Policy Statement.
What We Offer
•A collaborative teamwork environment where learning is constant, and performance is rewarded.
•The opportunity to be part of the team that is revolutionizing the treatment of some of the world's most devastating diseases.
•A generous benefits package for eligible employees that includes medical, dental, vision, life, AD&D, short and long-term disability insurance, 401(k) with employer match, an employee stock purchase plan, paid parental leave, eleven paid company holidays per year, a minimum of fifteen days of accrued vacation per year, which increases with tenure, and paid sick time in compliance with applicable law(s).
 
Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures, and markets novel products and has a broad portfolio that addresses challenging medical conditions in markets with significant unmet need. Penumbra sells its products to hospitals and healthcare providers primarily through its direct sales organization in the United States, most of Europe, Canada, and Australia, and through distributors in select international markets. The Penumbra logo is a trademark of Penumbra, Inc.
 
Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, age, disability, military or veteran status, or any other characteristic protected by federal, state, or local laws.
 
If you reside in the State of California, please also refer to Penumbra's Privacy Notice for California Residents.
 
For additional information on Penumbra’s commitment to being an equal opportunity employer, please see Penumbra's AAP Policy Statement.
undefined

Similar Jobs

InMobiInMobi - Lead - Revenue Strategy

InMobiInMobi

Bengaluru, Karnataka, India (On-Site)
2 Months ago
NVIDIA - Senior Storage and Data Production Engineer

NVIDIA

Santa Clara, California, United States (On-Site)
3 Weeks ago
Canva - Education Account Executive, K12 (Contract)

Canva

Warsaw, Masovian Voivodeship, Poland (Remote)
6 Months ago
Tencent - NIKKE Game Data Analyst

Tencent

Shenzhen, Guangdong Province, China (On-Site)
1 Month ago
Dmg - Software Development Engineer 4

Dmg

Bengaluru, Karnataka, India (On-Site)
5 Months ago
Microsoft - Principal Data Science Manager

Microsoft

Hyderabad, Telangana, India (On-Site)
5 Days ago
ByteDance - Business Analyst

ByteDance

Seattle, Washington, United States (On-Site)
1 Week ago
Maersk Careers - Vendor Master Data Lead

Maersk Careers

Bengaluru, Karnataka, India (On-Site)
340 Years ago
Fliff  Inc  - Data Scientist

Fliff Inc

Austin, Texas, United States (On-Site)
9 Months ago
The Walt Disney Company - Senior Machine Learning Engineer

The Walt Disney Company

New York, New York, United States (On-Site)
1 Week ago

Get notifed when new similar jobs are uploaded

Similar Skill Jobs

NVIDIA - Senior System Validation Engineer

NVIDIA

Yokne'am Illit, North District, Israel (On-Site)
3 Months ago
Reliance Industries  - Lead Reservoir Engineer ( 81732533 )

Reliance Industries

Navi Mumbai, Maharashtra, India (On-Site)
5 Months ago
Google - Product Activation Manager, Partner Sales, YouTube

Google

New York, New York, United States (On-Site)
3 Days ago
Ubisoft - Regional Project Intelligence Director (Nordics & Romania)

Ubisoft

Malmö, Skåne County, Sweden (Hybrid)
1 Week ago
CrazyLabs - Game Designer

CrazyLabs

Berlin, Berlin, Germany (On-Site)
2 Weeks ago
Google - Operations Excellence Manager, Global Vendor Operations, YouTube

Google

Bengaluru, Karnataka, India (On-Site)
3 Days ago
Netflix - Engineering Manager, Telemetry & Logging - Infrastructure

Netflix

United States (Remote)
3 Days ago
Daybreak Game Company LLC - Executive Producer - MTGO

Daybreak Game Company LLC

San Diego, California, United States (Hybrid)
5 Months ago
Microsoft - Senior Security Data Scientist

Microsoft

Redmond, Washington, United States (On-Site)
5 Days ago
Google - Technical Program Manager II, Data Center Quality, Cloud Supply Chain

Google

Council Bluffs, Iowa, United States (On-Site)
1 Day ago

Get notifed when new similar jobs are uploaded

Jobs in undefined

Looks like we're out of matches

Set up an alert and we'll send you similar jobs the moment they appear!

Data Analyst Jobs

Meta - Data Scientist, Product Analytics

Meta

Los Angeles, California, United States (Remote)
3 Days ago
Scorewarrior - Data Analyst

Scorewarrior

Limassol, Limassol, Cyprus (On-Site)
2 Weeks ago
NVIDIA - Senior C++ Software Engineer - Apache Spark Solution

NVIDIA

Shanghai, Shanghai, China (On-Site)
3 Months ago
Jagex - Senior Product Analyst - Old School RuneScape

Jagex

Cambridge, England, United Kingdom (Remote)
1 Month ago
Animoca Brands - Quant Researcher

Animoca Brands

Hong Kong (On-Site)
6 Months ago
Baldor Technologies  - RevOps Analyst

Baldor Technologies

Mumbai, Maharashtra, India (On-Site)
7 Months ago
Mistplay - Senior Market Insights Specialist

Mistplay

Montreal, Quebec, Canada (Hybrid)
3 Weeks ago
Google - Data Scientist, gTech Ads Solutions

Google

Bengaluru, Karnataka, India (On-Site)
4 Days ago
Avathon - Data Engineer

Avathon

Bengaluru, Karnataka, India (On-Site)
6 Months ago
Epic Games - Senior Data Analyst, Unreal Engine & Creator Products

Epic Games

Cary, North Carolina, United States (On-Site)
3 Months ago

Get notifed when new similar jobs are uploaded

About The Company

Gold Coast, Queensland, Australia (Remote)

Alameda, California, United States (Hybrid)

Western Australia, Australia (Remote)

Warsaw, Masovian Voivodeship, Poland (Remote)

Philadelphia, Pennsylvania, United States (Remote)

View All Jobs

Get notified when new jobs are added by Penumbra

Level Up Your Career in Game Development!

Transform Your Passion into Profession with Our Comprehensive Courses for Aspiring Game Developers.

Job Common Plug