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Company

Original Job Post

Alexion Pharmaceuticals, Inc. · 1 week ago

Associate Director, Biostatistics

Boston, MA

Full-time

Hybrid

Director

7+ years exp

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BiotechnologyHealth Care

H1B Sponsorship

Comp. & Benefits

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Responsibilities

Lead and manage team of internal and external biostatistics and statistical programming resources supporting studies and programs for identified therapeutic area(s) or phase(s) of development. Manage assignments and priorities of team members.

Ensure accurate, statistically valid deliverables included in protocols, statistical analysis plans, study reports, manuscripts, and regulatory submission documents.

Coordinate achievement of major statistical deliverables and milestones in collaboration with other functions.

Leverage standardization to maximize global data integration and interpretability.

Provide statistical leadership and support for feasibility assessments, clinical development plans, complex study designs, regulatory meetings, submissions and follow up.

Responsible for providing statistical leadership for preparation of marketing applications (NDA/BLA) to FDA, EMA or other worldwide regulatory agencies.

Apply innovative statistical approaches to the design of studies and to the analysis/reporting of study results (e.g., modeling and simulation, adaptive design and /or Bayesian approaches)

Keeps abreast of literature/advancements in science/medicine/technology in own and related fields of the drug development program.

Monitors project progress and ensures proper resource allocation for successful project deliverables against goals and timelines.

Qualification

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Statistical MethodologyClinical Trials DesignBayesian ModelingAdaptive DesignRegulatory Requirements KnowledgeBLA/NDA ExperienceECTD SubmissionsStatistical Software Programs (SAS)CDISC Requirements KnowledgeSDTMADaM Communication SkillsInterpersonal SkillsFlexibleWell-Organized Work Under Pressure

Required

A PhD in Statistics/Biostatistics and at least 7 years of relevant pharmaceutical experience or a MSc in Statistics/Biostatistics and at least 10 years of relevant pharmaceutical experience

Comprehensive knowledge of statistical methodology in design and analysis of clinical trials including Bayesian modeling and adaptive design

Knowledge of regulatory requirements relating to clinical development of drugs and biologics

BLA/NDA experience including eCTD submissions

Working knowledge of major statistical software programs including SAS

Knowledge of CDISC requirements for SDTM and ADaM

Excellent verbal and written communication skills, and excellent inter-personal skills

Flexible, well-organized, and possess the ability to work well under pressure

Preferred

PhD in Statistics/Biostatistics preferred

Company

Alexion Pharmaceuticals, Inc.

Glassdoor

3.9

Alexion, AstraZeneca Rare Disease was created following the 2021 acquisition of Alexion Pharmaceuticals, Inc. by AstraZeneca.

Founded in 1992

Cheshire, Connecticut, USA

1,001-5,000 employees

https://alexion.com

H1B Sponsorship

Alexion Pharmaceuticals, Inc. 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

2023 (34)

2022 (30)

2021 (26)

2020 (18)