Associate Director, Biostatistic
Company: Sun Pharmaceutical Industries, Inc.
Location: Cranbury
Posted on: October 5, 2024
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Job Description:
The Company
Sun Pharmaceutical Industries Ltd. (Sun Pharma) is the fourth
largest specialty generic pharmaceutical company in the world with
global revenues of over US$ 5.1 billion. We provide high-quality,
affordable medicines trusted by customers and patients in over 100
countries. From humble beginnings in 1983, Sun Pharma has grown to
become one of the largest generic pharmaceutical companies
worldwide. We are the largest pharmaceutical company in India.
In the US, we are among the top 10 generic pharmaceutical companies
and are ranked second by prescriptions in the generic dermatology
market. We are the largest Indian company in emerging markets with
a presence in over 80 markets. Brazil, Mexico, Russia, Romania and
South Africa are some of our key emerging markets. We are present
across all major markets in Western Europe, Canada, Australia, New
Zealand, Japan and China among others. Our presence in emerging
markets and the developing world enables our teams to cross-sell
and build brands with ease.
Sun Pharma's global presence is supported by more than 40
manufacturing facilities spread across 5 continents, R&D
centers across the globe and a multi-cultural workforce comprising
over 50 nationalities. Sun Pharma fosters excellence through
innovation supported by strong R&D capabilities comprising
around 2,000 scientists and R&D investments of over 7-8% of
annual revenues. As a key growth driver for the company, Sun Pharma
is strengthening its specialty pipeline by developing innovative
medicines that help meet unmet medical needs in the areas of
dermatology, ophthalmology and derma-oncology.
Products
Our core strength lies in our ability to excel in developing
generics and technologically complex products backed by our
dedicated teams in formulations, process chemistry, and analytical
development. We manufacture and market a large basket of
pharmaceutical formulations covering a broad spectrum of chronic
and acute therapies. It includes generics, branded generics,
specialty, complex or difficult to make technology-intensive
products, over-the-counter (OTC), antiretrovirals (ARVs), Active
Pharmaceutical Ingredients (APIs) and Intermediates. Our broad
portfolio of more than 2000 high quality molecules covers multiple
dosage forms, including tablets, capsules, injectables, inhalers,
ointments, creams, and liquids.
Every year, we sell over 30 billion doses covering
neuro-psychiatry, cardiology, gastroenterology, anti-infectives,
diabetology, oncology, ophthalmology, dermatology, urology,
nephrology and respiratory among others. Our capabilities extend
beyond the development of differentiated products, including
liposomal products, inhalers, lyophilized injections, nasal sprays,
and controlled release dosage forms.
Position Summary
Sun Pharma is seeking an experienced and motivated Senior Principal
Statistician or Associate Director of Biostatistics to join our
rapidly growing organization. Reporting to the Senior Director,
Biostatistics Lead, this position will be responsible for
supporting the design, execution, analysis and interpretation of
registration-directed clinical trials and global regulatory
submissions. This person will work cross-functionally with internal
departments and external resources on Biostatistics-related issues,
ensure adherence to relevant regulatory requirements and company
Standard Operating Procedures (SOPs) as appropriate, and apply
technical expertise to the development of biostatistics standards
and procedures.
Responsibilities
Serve as study biostatistician on development programs and multiple
studies.
Author statistical analysis plan, TFL shells and other
study-related statistical documents.
Review AdaM Specification, oversee the generation of AdaMs and TFLs
and ensure timely high-quality deliverables.
Plan and implement statistical analyses, provide statistical input
to the clinical study report and perform statistical functions for
submission-related activities on the assigned programs.
Plan and execute exploratory analyses and statistical consultation
within applicable cross-functional teams.
Provide statistical support for Health Authority requests,
publications, presentations, and posters at medical
conferences/symposia, as assigned.
Contribute to the development and implementation of innovation in
statistical methodology and trial design; perform simulations to
assess various study design options and analysis approaches.
Attend and make statistical contributions at cross-functional study
team and project team meetings.
Participate in process improvement, SOP development, training, and
enhancing statistical technical expertise.
Maintain a positive, results orientated work environment, building
partnerships and modeling teamwork, and communicating to the team
in an open, balanced and objective manner.
Adhere to departmental and regulatory agency procedures and
standards.
Required Qualifications
Ph.D. or M.S. in Biostatistics or Statistics.
At least 8+ years for PhD (or 10+ years for M.S.) for Associate
Director.
Demonstrated good understanding of Phase I to Phase IV drug
development.
Strong knowledge in the principles and techniques of statistical
analysis, interpretation, and clinical relevance.
Knowledge of statistical analysis software SAS and R.
NDA/BLA experience with eCTD submission is a plus.
Dermatology or oncology drug development experience is a plus.
Excellent organizational skills, time management, and ability to
coordinate workload and meet established deadlines.
Excellent verbal and written skills, allowing for an open and
effective dialogue throughout the company.
Attention to detail and quality are critical to success.
Highly accountable for the results and outcomes of their
responsibilities and understands the impact of their efforts,
results, and attitudes on others.
Use teamwork to work cooperatively toward the most effective
solutions, championing the best ideas of team members, and
assisting where help is needed yet is capable of highly independent
work when efficiency is required.
Results-oriented individual who is highly motivated, decisive,
flexible in thought, and has the creativity to excel in and
contribute to a rapidly growing company.
Forward thinking mindset with the ability to manage multiple
projects, and identify and resolve issues.
Broad experience in an emerging, publicly traded company
environment is a plus.
Actual base compensation may vary based on a number of factors,
including but not limited to geographical location and experience.
In addition, this position is part of the Annual Performance Bonus
Plan. Employees are eligible to participate in Company employee
benefit programs which include medical, dental and vision coverage;
life insurance; disability insurance; 401(k) savings plan; flexible
spending accounts; and the employee assistance program. Employees
also receive various paid time off benefits, including vacation
time and sick time.
The compensation and benefits described above are subject to the
terms and conditions of any governing plans, policies, practices,
agreements, or other materials or documents as in effect from time
to time, including but not limited to terms and conditions
regarding eligibility. If hired, employee will be in an "at-will
position" and the Company reserves the right to modify base salary
(as well as any other discretionary payment or compensation
program) at any time, including for reasons related to individual
performance, Company, or individual department/team performance,
and market factors.
The preceding job description has been designed to indicate the
general nature and level of work performed by employees within this
classification. It is not designed to contain or be interpreted as
a comprehensive inventory of all duties, responsibilities and
qualifications required of employees as assigned to this job.
Nothing herein shall preclude the employer from changing these
duties from time to time and assigning comparable duties or other
duties commensurate with the experience and background of the
incumbent(s).
We provide equal employment opportunities for all current employees
and applicants for employment. This policy means that no one will
be discriminated against because of race, religion, creed, color,
national origin, nationality, citizenship, ancestry, sex, age,
marital status, physical or mental disability, affectional or
sexual orientation, military or veteran status, generic
predisposing characteristics or any other basis prohibited by
law.
Keywords: Sun Pharmaceutical Industries, Inc., Reading , Associate Director, Biostatistic, Executive , Cranbury, Pennsylvania
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