Associate Director, Biostatistics
Alexion

Job Info

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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:

• 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.

You will need to have:

• 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.

We would prefer for you to have:

• PhD in Statistics/Biostatistics preferred .

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working give us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

#LI-MH1

#LI-HYBRID

Date Posted
17-Nov-2023

Closing Date

Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact accommodations@Alexion.com. Alexion participates in E-Verify.

AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law

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