Sr Mgr Biostatistics
Teva Pharmaceuticals · Karnataka, India
Full-time · Senior · Posted 14 days ago
WE ARE TEVA
We’re Teva, a leading innovative biopharmaceutical company, enabled by a
world-class generics business. Whether it’s innovating in the fields of
neuroscience and immunology or delivering high-quality medicine worldwide, we’re
dedicated to addressing patients’ needs now and in the future. Here, you will be
part of a high-performing, inclusive culture that values fresh thinking and
collaboration. You'll have the room to grow, the flexibility to balance life
with work, and the opportunity to better health worldwide, together.
THE OPPORTUNITY
The Senior Manager Clinical Statistics position is for a skilled statistician
with formal training in statistics and some experience in drug development and
clinical research. He or she is expected to provide statistical support to
clinical studies or programs within Teva Global R&D. The support includes, but
is not limited to, strategic planning, study designs, data analyses, and
regulatory interactions with the guidance of a senior level GSD statistician. He
or she is expected to have extensive knowledge about statistical principles and
the ability to use appropriate software and tools to perform his or her tasks. A
Senior Manager Clinical Statistician should begin to act as an independent
individual contributor with respect to their assignments. They should begin to
attain and exercise leadership qualities with the guidance of a senior level GSD
statistician. In addition, he/ she should exercise situational awareness as
they begin creative and strategic thinking that is appropriate for their
assignments. They must have excellent written and oral communication skills and
demonstrate the ability to successfully work in a global environment.
HOW YOU’LL SPEND YOUR DAY
* May begin to work at the Product/Program level assignments under the guidance
of a senior GSD statistician.
* Independently take on responsibilities for delivering on assignments with
quality and within timelines.
* May oversee contingent workers and/or vendors; may provide training to
others.
* May take on responsibilities for statistical aspects of study designs (sample
size planning, endpoint assessment, etc.) and data analyses with the guidance
of a senior level GSD statistician.
* Prepares, or oversees the preparation of statistical sections of clinical
protocols in collaboration with their supervisor or a senior level GSD
statistician.
* Writes or may oversee the writing of statistical analysis plans with an
appropriate level of guidance.
* Support or may oversee the support of statistical analyses for the writing of
clinical study reports, abstracts, manuscripts, and other documents for the
marketing of Teva products
* Performs statistical analyses in line with the strategic plans for global
regulatory submissions, such as briefing packages, integrated analyses, and
regulatory responses.
* Collaborate with outsourcing partners and may oversee the statistical aspects
of outsourced studies, as appropriate.
* Identifies processes that may require improvement and communicates this to
GSD management in an appropriate manner.
* Participates in department initiatives to further the effectiveness of global
statistics.
* Begins to evaluate and possibly implement innovative clinical trial design
and analysis that are appropriate in adding value to the clinical development
program.
YOUR QUALIFICATIONS AND EXPERIENCE
* Ph.D./MS in Statistics/Biostatistics (or related field).
* MS with a minimum of 4 years of related experience; PhD with a minimum of 2
years of related experience.
* Provides independent statistical support to clinical studies with the
guidance of senior level statisticians (i.e., Associate Director or higher).
Provides sample size planning in accordance with the study design and
analysis. May provide study design input and consultation for study endpoint
assessment. Must exhibit situational awareness in considering innovative
clinical trial design and analysis.
* Independent contributor to assigned studies under moderate supervision.
* Tackles difficult problems; Identifies possible solutions; and works with
his/her supervisor for appropriate resolution.
* May leads process development and improvement.
* Competent in the planning, analysis and reporting of clinical trials of
moderate complexity.
* Ability to work in an outsourcing model (fully or functional outsourcing)
* Good organizational and problem-solving skills.
* Ability to program using SAS or JMP, knowledge of R is beneficial.
* Knowledge of relevant ICH, FDA and CHMP guidelines
HOW WE’LL TAKE CARE OF YOU
At Teva India, care is at the heart of how we work. From your first
day, you’ll be welcomed into a people-first culture built on inclusion, respect,
and belonging.
That support extends to you and your loved ones through benefits designed for
real life. These include comprehensive medical insurance, OPD coverage, annual
health checkups, term life and accident insurance, and confidential emotional
wellbeing support through our Optum Employee Assistance Program. You’ll also
enjoy healthy meals at work, holistic wellbeing initiatives, and volunteering
programs that help you give back to the community.
Your growth matters too. You’ll have opportunities to build future-ready skills,
collaborate on projects with global teams, explore internal career
opportunities, and learn through programs such as our AI-enabled Teva Twist
program, R&D Academy, continuing education, and mentorship.
Join our vibrant workplace, where we celebrate milestones, festivals,
achievements, and community impact together.
ALREADY WORKING @TEVA?
Make sure to apply through our internal career site on Twist—your one-stop shop
for career development
TEVA’S EQUAL EMPLOYMENT OPPORTUNITY COMMITMENT
Teva Pharmaceuticals is committed to equal opportunity in employment. It is
Teva's global policy that equal employment opportunity be provided without
regard to age, race, creed, color, religion, sex, disability, pregnancy, medical
condition, sexual orientation, gender identity or expression, ancestry, veteran
status, national or ethnic origin or any other legally recognized status
entitled to protection under applicable laws. We are committed to a diverse and
inclusive workplace for all. If you are contacted for a job opportunity, please
advise us of any accommodations needed to support you throughout the recruitment
and selection process. All accommodation information provided will be treated as
confidential and used only for the purpose of providing an accessible candidate
experience.