28 applicants

Company

Original Job Post

Rocket Pharmaceuticals · 1 week ago

Director, Biostatistics

United States

Full-time

Remote

Director

$216K/yr - $259K/yr

8+ years exp

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BiotechnologyGenetics

H1B Sponsorship

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Responsibilities

Leads or contributes to all statistical activities of the assigned gene therapy programs, including statistical input to development strategies from first-in-human trial to life cycle management, clinical studies, and regulatory submissions (e.g., BLA and MAA)

Leads collaboration with internal and external (e.g., CRO) team members to coordinate the planning and execution of statistical deliverables

Leads/conducts statistical modeling to enable innovative and optimal statistical designs and to address identified or potential statistical issues arising in programs or studies

Contributes to clinical protocol development, including authoring of the Statistics section and reviewing of other sections by applying statistical principles

Authors or oversees statistical analysis plans for clinical trials and integrated summaries of safety/effectiveness (ISS/ISE), and oversees the development of shells for tables, figures and listings

Reviews case report form (CRF) designs to ensure data collection meet the requirements of statistical analyses

Designs and specifies randomization schedules; reviews and approves test randomization lists

Provides statistical input to data monitoring committee (DMC) charters, independent review charters, and other study-level documents

Provides guidance to statistical programmers on ADaM and tables/figures/listings

Ensures QC/QA of statistical deliverables including validation of key analysis results

Performs ad hoc and exploratory statistical analyses as needed

Provides statistical input to natural history studies based on program goals such as understanding of the endpoints and potential need of external control analyses

Contributes to clinical study reports, DSUR and CTD sections 2.7.3 and 2.7.4, including authoring of statistical methods and interpretation of analysis results

Addresses or helps to address statistical questions/comments from FDA and other regulatory agencies, and reviews and addresses comments by IRB/ECs

Supports and ensures the data accuracy of publications including manuscripts and presentations

Contributes or leads standardization and process improvement efforts for Biostatistics and contributes to cross-functional process improvement efforts

Represents Rocket regarding statistical issues in meetings with regulatory agencies and other external parties

Oversees statistical vendors in collaboration with Statistical Programming with respect to key performance indicators, metrics, and key deliverables and timelines

Contributes to project budget/resource planning, re-forecasting, and milestones, in collaboration with other functions

Serves as a mentor to junior team members as applicable

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

Clinical trials designRegulatory submissionsStatistical methodsFDA regulationsStatistical programming SASStatistical programming RStatistical simulationsTrial design softwareCDISC standardsOverseeing statistical servicesStatistical communicationOrganizationWork independentlyProblem-SolvingEffective communicationCollaborationRare DiseasesGene Therapies

Required

Ph.D. or Masters degree in Statistics or a related field

At least 8 years (12 years for Master) of experience in the pharmaceutical/biotech industry

Demonstrated ability and experience in the design, analysis and reporting of clinical trials

Experience in NDAs, MAAs or other regulatory submissions

In-depth knowledge of statistical methods for clinical trials, including both frequentist and Bayesian approaches

Knowledge of FDA, EMA and ICH regulations and guidelines

Proficient in statistical programming (SAS and R)

Proven ability to use statistical simulations to account for uncertainty and in scenario planning for study design and key analyses

Experience with trial design software (e.g., EAST or nQuery)

Strong organization skills and ability to concurrently work on studies

Familiarity with CDISC standards, including SDTM and ADaM

Adept at overseeing statistical services provided by CRO’s and/or contractors

Ability to work independently for most activities and seek guidance/support when necessary to address issues and solve problems

Ability to effectively communicate statistical concepts in a clear and concise manner both written and verbally

Ability to collaborate, communicate and interact effectively in a fast-paced team environment

Preferred

Experience with rare diseases or gene therapies are desirable but not required

Benefits

Stock Options

Excellent Health Benefits

Company

Rocket Pharmaceuticals

Rocket Pharmaceuticals is a biotech company that develops a pipeline of genetic therapies for rare childhood disorders.

Founded in 2015

Cranbury, New Jersey, USA

201-500 employees

http://www.rocketpharma.com/

H1B Sponsorship

Rocket Pharmaceuticals has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Trends of Total Sponsorships

2022 (2)

2020 (1)