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Associate Director, Biostatistics
$138k-179k (estimate)
Full Time | Pharmaceutical
4 Months Ago
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Alexion Pharmaceuticals,Inc. is Hiring an Associate Director, Biostatistics Near Boston, MA
This is what you will do:The Associate Director, Biostatistics oversees all biostatistics activities for one or more clinical programs to ensure timely and accurate delivery of statistical designs, analyses, and reports and regulatory submissions. Independently provides strategic statistical input to drug development including feasibility assessments, development plans, complex study designs, cross-study statistical methodology, interpretations, regulatory submissions and follow up. Contributes to establishing and driving compound level program functional strategy for resourcing, processes and standards to achieve quality and maximize efficiency. Works closely with Physicians, Clinical Operations, Pharmacovigilance, and Regulatory teams to plan and implement clinical studies as part of a larger clinical development plan, and to analyze and interpret clinical study data. Represents Biostatistics in core project teams on operational and strategic decisions related to assigned projects. This individual is also accountable for the production of biostatistics deliverables, managing a team of internal and external biostatistics and statistical programming resources.
You will be responsible for:
You will be responsible for:
- 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.
- 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.
- The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.
- PhD in Statistics/Biostatistics preferred .
Job Summary
JOB TYPE
Full Time
INDUSTRY
Pharmaceutical
SALARY
$138k-179k (estimate)
POST DATE
03/21/2023
EXPIRATION DATE
07/01/2024
WEBSITE
alexion.com
HEADQUARTERS
BOSTON, MA
SIZE
3,000 - 7,500
FOUNDED
1992
TYPE
Public
CEO
LUDWIG N HANTSON
REVENUE
$5B - $10B
INDUSTRY
Pharmaceutical
Related Companies
About Alexion Pharmaceuticals,Inc.
Alexion develops and commercializes immunoregulatory drugs for the treatment of autoimmune and cardiovascular diseases.
Show more
The following is the career advancement route for Associate Director, Biostatistics positions, which can be used as a reference in future career path planning. As an Associate Director, Biostatistics, it can be promoted into senior positions as a Top Clinical Information Systems Executive that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Associate Director, Biostatistics. You can explore the career advancement for an Associate Director, Biostatistics below and select your interested title to get hiring information.
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